Study · A Phase III, Randomized, Do…

A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer

active NCT-SIMULATED-301

Torivumab (programmed death receptor-1 blocking antibody) + platinum-based chemotherapy

Phase III Non-Small Cell Lung Cancer Sponsor Simulated Sponsor (synthetic data) FPI 2025-08-18

Study design

Design: Phase III, interventional, randomized, double blind, parallel, placebo-controlled, 2 arms, add-on to platinum-based chemotherapy; trial type: efficacy; indication type: treatment; population: Advanced or metastatic non-small cell lung cancer blinded
Arms (2): Placebo + ChemotherapyTorivumab + Chemotherapy
Primary endpoint: Overall survival
Enrollment: 317 of 450 target
Data cutoff: 2026-09-19
Provenance: clinTrialData v0.1.2 — onco_phase3_solid

LicenseSynthetic / educational use only — fictional data

UpstreamSimulated Sponsor (synthetic data)

Extracted 2026-09-19

Open source record

Agentic orchestration

Runs all 13 lifecycle agents below in order; each records what it did, the evidence it used, and escalates to a human only on exception.

Horizon 3

Idle — the checklist below shows the last recorded state of every step.

Study lifecycle checklist 12 / 13

13 steps in trial order. Expand a step to see exactly what the agent did, the evidence it computed, and what it produced; steps needing a decision link to the review queue.

Decisions awaiting you 27

Every escalation the agents raised on this study, decided here exactly as on the dashboard. Open an item's details before deciding; a note goes on the audit trail.

deciding as portal.reviewer

critical adverse_event · assess_serious_event

SAE — SAE Narrative Subject SITE001-0066 (58-year-old male) experienced a serious adverse event graded as Grade 3 in severity. The event term has not yet been coded; system organ class is [PENDING — human input]. Source information: Participant-reported via Luna chat: "severe shortness of breath and chest pain since this morning." This is a solicited symptom report and requires clinical characterization. Onset date: [PENDING — human input]. Treatment arm: withheld, as the study remains blinded. Action taken with study treatment: [narrative drafted by claude-sonnet-5; verify against source fields]

high protocol · approve_protocol_draft

Protocol v0.1-auto (pending_review) for study "A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer" needs medical review. 61 SPIRIT items checked, 42 gaps: 2 critical, 18 major, 22 minor; amendment risk 1.0 (heuristic weights 0.04/0.08/0.15). Critical: data monitoring committee or safety review committee (SPIRIT 21a) — left as placeholder; harms plan: harm stopping criteria / formal stopping rules (SPIRIT 21b / Phillips 2019) — left as placeholder. The reviewer decides whether the draft is approved, revised or rejected.

Edit and re-lint

Escalated by protocol_agent claude-sonnet-5 · 20 d ago · took 12.9 s

medium study · import_matched_candidates

Screening plan for "A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer": 60 candidates to screen over the next 30 days across 15 open sites (Pace: pace ratio 1.02 vs pro-rata plan (317/450 accrued, ~309 expected by now); projected last-patient-in 2027-03-14 at the trailing-3-month pace (23.0/month). eligibility yield Y=0.4850). Per site — SITE001 (USA): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4) · SITE002 (USA): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4) · SITE003 (CAN): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4) · SITE004 (DEU): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4) · SITE005 (FRA): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4) · SITE006 (GBR): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4; 19 consents vs site median 21.0) · SITE007 (JPN): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4; 19 consents vs site median 21.0) · SITE008 (KOR): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4; 19 consents vs site median 21.0) · SITE009 (AUS): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4; 20 consents vs site median 21.0) · SITE010 (ESP): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4; 20 consents vs site median 21.0) · SITE011 (ITA): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4) · SITE012 (BRA): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4) · SITE013 (USA): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4) · SITE014 (NLD): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4; 19 consents vs site median 21.0) · SITE015 (POL): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4). Source: partner:ehr-matching (planning estimate). Approve import for screening — matching never auto-enrolls.

Escalated by recruitment_agent claude-sonnet-5 · 20 d ago · took 4.9 s

high site · confirm_onsite_visit

Site "SITE006 (GBR)" is a statistical outlier among the 15 sites of "A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer" (risk score 0.459; withdrawal rate 11% vs study mean 2%, z=3.01; SAE rate 0.68 vs study mean 0.31, z=2.29; enrollment per open month 1.46 vs study mean 1.71, z=-1.64). An on-site visit is proposed for 2026-10-03; the other sites stay on remote/centralized monitoring.

Escalated by monitoring_agent claude-sonnet-5 · 20 d ago · took 4.0 s

medium study · review_aged_queries

4 data queries are open past the 14-day SLA on "A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer" (4 past 30 days, 0 safety-critical P1). JSCDM benchmark: ≥80% reviewed within 2 weeks, target 95%. Oldest: [AE-001 · 285 d] AE Fatigue (grade 1) for SITE002-0071 has onset 2025-12-08, 1 d before first dose on 2025-12-09. Confirm onset; [AE-001 · 251 d] AE Asthenia (grade 1) for SITE012-0100 has onset 2026-01-11, 1 d before first dose on 2026-01-12. Confirm onse; [AE-001 · 106 d] AE Anaemia (grade 1) for SITE010-0221 has onset 2026-06-05, 1 d before first dose on 2026-06-06. Confirm onset; [AE-001 · 31 d] AE Diarrhoea (grade 2) for SITE014-0280 has onset 2026-08-19, 1 d before first dose on 2026-08-20. Confirm ons

Escalated by cdm_agent claude-sonnet-5 · 20 d ago · took 4.3 s

critical adverse_event · assess_serious_event

OVERDUE SAE — SAE Narrative Subject SITE012-0012 (58-year-old male) experienced a serious adverse event of Grade 3 Diarrhoea (System Organ Class: Gastrointestinal disorders), meeting seriousness criteria of hospitalization. Onset date: 2026-08-20. Resolution date: 2026-08-30. Outcome: RECOVERED/RESOLVED. Study treatment arm: withheld — study is blinded. Action taken with study treatment: DRUG WITHDRAWN. Causality assessment: Investigator causality assessment has not been completed. [PENDING — human input] Expectedness: Reported as expected for the anti-PD-1 class per the pembrolizumab label. Expedited reporting: Expedited due date on record is 2026-09-04. This deadline appears to be OVERDUE based on the data provided. Although the event is described as label-listed, confirmation is required from the physician as to whether expedited reporting still applies. [PENDING — human input] Death within 30 days: No. Additional source description on file: Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-02-13 ( Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78. [narrative drafted by claude-sonnet-5; verify against source fields]

Escalated by safety_agent claude-sonnet-5 · 20 d ago · took 21.6 s

critical adverse_event · assess_serious_event

OVERDUE SAE — Subject SITE013-0278 (64-year-old F) experienced Grade 3 Asthenia (General disorders and administration site conditions), serious (hospitalization). Onset 2026-08-30; ongoing. Outcome: NOT RECOVERED/NOT RESOLVED. Action taken with study treatment: DOSE REDUCED. Investigator causality NOT RELATED (not suspected). Expectedness: expected for anti-PD-1 class per pembrolizumab label. Existing expedited deadline 2026-09-14 kept although the term is label-listed — physician to confirm whether expedited reporting still applies — OVERDUE. Arm withheld: study is blinded. Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78.

critical adverse_event · assess_serious_event

OVERDUE SAE — Subject SITE015-0227 (61-year-old M) experienced Grade 3 Neutropenia (Blood and lymphatic system disorders), serious (hospitalization). Onset 2026-09-01; ongoing. Outcome: NOT RECOVERED/NOT RESOLVED. Action taken with study treatment: DRUG WITHDRAWN. Investigator causality NOT RELATED (not suspected). Expectedness: expected for anti-PD-1 class per pembrolizumab label. Existing expedited deadline 2026-09-16 kept although the term is label-listed — physician to confirm whether expedited reporting still applies — OVERDUE. Arm withheld: study is blinded. Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78.

critical adverse_event · assess_serious_event

OVERDUE SAE — Subject SITE007-0138 (59-year-old F) experienced Grade 4 Fatigue (General disorders and administration site conditions), serious (life-threatening). Onset 2026-09-02, resolved 2026-09-13 (11 days). Outcome: RECOVERED/RESOLVED. Action taken with study treatment: DOSE REDUCED. Investigator causality RELATED (suspected). Expectedness: expected for anti-PD-1 class per pembrolizumab label. Existing expedited deadline 2026-09-17 kept although the term is label-listed — physician to confirm whether expedited reporting still applies — OVERDUE. Arm withheld: study is blinded. Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78.

critical adverse_event · assess_serious_event

SAE — Subject SITE005-0273 (79-year-old F) experienced Grade 3 Thrombocytopenia (Blood and lymphatic system disorders), serious (hospitalization). Onset 2026-09-05; ongoing. Outcome: NOT RECOVERED/NOT RESOLVED. Action taken with study treatment: DOSE REDUCED. Investigator causality not assessed — investigator assessment required. Expectedness: expected for anti-PD-1 class per pembrolizumab label. Existing expedited deadline 2026-09-20 kept although the term is label-listed — physician to confirm whether expedited reporting still applies. Arm withheld: study is blinded. Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78.

critical adverse_event · assess_serious_event

SAE — Subject SITE006-0258 (61-year-old M) experienced Grade 3 Nausea (Gastrointestinal disorders), serious (hospitalization). Onset 2026-09-05, resolved 2026-09-10 (5 days). Outcome: RECOVERED/RESOLVED. Action taken with study treatment: DOSE REDUCED. Investigator causality NOT RELATED (not suspected). Expectedness: expected for anti-PD-1 class per pembrolizumab label. Existing expedited deadline 2026-09-20 kept although the term is label-listed — physician to confirm whether expedited reporting still applies. Arm withheld: study is blinded. Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78.

critical adverse_event · assess_serious_event

SAE — SAE Narrative Subject SITE015-0186 (50-year-old male) experienced a serious adverse event of Constipation (Gastrointestinal disorders), Grade 4, assessed as serious due to life-threatening criteria. Onset: 2026-09-10. Outcome at time of reporting: NOT RECOVERED/NOT RESOLVED. Note: The source description associated with this event records onset as 2023-03-06 (study day 134) and outcome as RECOVERED/RESOLVED, which conflicts with the onset and outcome fields above. This discrepancy has not been resolved in the Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78. [narrative drafted by claude-sonnet-5; verify against source fields]

critical adverse_event · assess_serious_event

SAE — Subject SITE001-0119 (62-year-old M) experienced Grade 4 Neutropenia (Blood and lymphatic system disorders), serious (life-threatening). Onset 2026-09-13; ongoing. Outcome: NOT RECOVERED/NOT RESOLVED. Action taken with study treatment: DOSE NOT CHANGED. Investigator causality NOT RELATED (not suspected). Expectedness: expected for anti-PD-1 class per pembrolizumab label. Existing expedited deadline 2026-09-28 kept although the term is label-listed — physician to confirm whether expedited reporting still applies. Arm withheld: study is blinded. Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78.

critical adverse_event · assess_serious_event

SAE — SAE Narrative Subject SITE011-0239 (49-year-old female) experienced a serious adverse event of Anaemia (System Organ Class: Blood and lymphatic system disorders), Grade 3, meeting seriousness criteria of hospitalization. Per the structured event data, onset occurred on 2026-09-13 and the event is ongoing, with an outcome of NOT RECOVERED/N Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78. [narrative drafted by claude-sonnet-5; verify against source fields]

medium study · proactive_retention_outreach

27 patient(s) at elevated dropout risk on "A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer": SITE013-0226 @ SITE013 (USA) p=0.472 (1 grade ≥3 AE(s), 1 serious AE(s) in last 60 d, treatment stopped 40 d ago); SITE013-0257 @ SITE013 (USA) p=0.472 (1 grade ≥3 AE(s), 1 serious AE(s) in last 60 d, treatment stopped 46 d ago); SITE006-0064 @ SITE006 (GBR) p=0.428 (2 grade ≥3 AE(s), treatment stopped 106 d ago, site withdrawal rate 10.5%); SITE002-0062 @ SITE002 (USA) p=0.401 (1 planned visit(s) missed, 1 grade ≥3 AE(s), treatment stopped 230 d ago); SITE005-0047 @ SITE005 (FRA) p=0.4 (2 grade ≥3 AE(s), treatment stopped 145 d ago, site withdrawal rate 4.8%); SITE005-0139 @ SITE005 (FRA) p=0.4 (2 grade ≥3 AE(s), treatment stopped 59 d ago, site withdrawal rate 4.8%); SITE006-0211 @ SITE006 (GBR) p=0.38 (3 grade ≥3 AE(s), 1 serious AE(s) in last 60 d, site withdrawal rate 10.5%); SITE001-0092 @ SITE001 (USA) p=0.378 (2 grade ≥3 AE(s), treatment stopped 152 d ago); SITE003-0051 @ SITE003 (CAN) p=0.378 (2 grade ≥3 AE(s), treatment stopped 245 d ago); SITE007-0085 @ SITE007 (JPN) p=0.378 (3 grade ≥3 AE(s), treatment stopped 188 d ago); SITE008-0067 @ SITE008 (KOR) p=0.378 (2 grade ≥3 AE(s), treatment stopped 163 d ago); SITE015-0117 @ SITE015 (POL) p=0.378 (2 grade ≥3 AE(s), treatment stopped 149 d ago); SITE005-0273 @ SITE005 (FRA) p=0.353 (4 grade ≥3 AE(s), 1 serious AE(s) in last 60 d, site withdrawal rate 4.8%); SITE011-0239 @ SITE011 (ITA) p=0.351 (2 grade ≥3 AE(s), 2 serious AE(s) in last 60 d, site withdrawal rate 4.2%); SITE013-0173 @ SITE013 (USA) p=0.351 (3 grade ≥3 AE(s), 1 serious AE(s) in last 60 d, site withdrawal rate 4.3%) … +12 more in the run evidence. Approve proactive site outreach before disengagement — no participant is contacted without this approval.

Escalated by retention_agent claude-sonnet-5 · 20 d ago · took 4.3 s

medium study · assess_termination_risk

1 early-termination risk flag(s) on "A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer": Serious-AE density 30.9% (98 serious AEs / 317 enrolled; threshold 30.0%, escalation-pressure proxy). Accrued 317 of 450 — pace ratio 102.5% of the pro-rata plan (~309 expected by month 14), trailing 3-month pace 22.72/month; projected last patient in 2027-03-16, 0.1 months ahead of plan (trailing 3-month pace). Implied early-termination probability 16.7% (base rate 23.5% from ClinicalTrials.gov Non-Small Cell Lung Cancer phase 3 (118/501 closed trials terminated; snapshot 2026-09-19T08:06:16Z); footprint 13 countries OR 0.65; Zhang & DuBois 2023, Cancer Med 12:5517–5525). ClinicalTrials.gov comparator Non-Small Cell Lung Cancer phase 3: 118 of 1025 registered trials terminated (11.5%; 23.5% of closed trials), 32 for accrual (27.1% of terminations); median enrollment 153.5 terminated vs 438 completed; e.g. NCT00003803, NCT00032084, NCT00091156. Termination is a human decision — only efficacy, safety, or feasibility justify it (Lièvre et al. 2001, BMJ 322:603–605).

Escalated by termination_watch_agent claude-sonnet-5 · 20 d ago · took 4.0 s

medium study · review_tmf_gaps

TMF for "A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer" is 65% complete against the DIA TMF Reference Model v3.2.1 (conduct stage); 8 auditable artifact(s) missing or incomplete — top gaps: 07.02.01 Expedited Safety Report, 02.01.02 Protocol, 03.01.01 Regulatory Submission. Confirm the filed TMF findings and assign owners.

Escalated by tmf_agent claude-sonnet-5 · 20 d ago · took 4.6 s

Agent reasoning trail 26 runs

Explainable, traceable, inspection-ready — every automated action records why it did what it did and the evidence it used (FDA/EMA January 2026 AI guiding principles).

When	Agent	Outcome	Model · duration	Reasoning
29 Sep 202621:14:08 UTC	tmf_agent H1	completed	Claude · claude-sonnet-5 4.9 s	This TMF self-audit against the DIA TMF Reference Model v3.2.1 (conduct stage) shows completeness of 0.66 against a threshold of 0.8, with 8 of 16 auditable artifacts present and 5 partial. The three top missing items ar…
29 Sep 202621:14:03 UTC	medical_writing_agent H1	completed	Claude · claude-sonnet-5 3.5 s	This is an interim, blinded draft (document status "pending_review," report_kind "interim"), following ICH E3 (CPMP/ICH/137/95) structure. Of 317 randomized subjects (target enrollment 450), 43 completed, 5 discontinued,…
29 Sep 202621:14:00 UTC	biostats_agent H1	escalated Review task #2a3c5b8f	Claude · claude-sonnet-5 3.4 s	This TLF batch (hash 476ab4f205a31270, 7 tables) is unchanged since the last run and is awaiting double-programming validation, per the deterministic summary. The study is blinded and active, with 317 randomised subjects…
29 Sep 202621:13:56 UTC	supply_agent partner	completed	Claude · claude-sonnet-5 3.5 s	The forecast projects 1,675 blinded kits (PLACEBO/TORIVUMAB) needed over the 6-month horizon, including a 15.0% kit buffer, versus 1,769 kits previously — a -5.3% change in demand, consistent with the escalation record. …
29 Sep 202621:13:53 UTC	termination_watch_agent H2	completed	Claude · claude-sonnet-5 3.8 s	Accrual is on track: 317 of 450 enrolled, pace ratio 102.5% of the pro-rata plan, trailing 3-month pace 22.72/month, projected last-patient-in 2027-03-16 (0.1 months ahead of plan). This is not near the accrual pace thre…
29 Sep 202621:13:49 UTC	retention_agent H2	completed	Claude · claude-sonnet-5 4.6 s	This run scored 269 active patients with a heuristic logistic model (coefficients are priors, not fitted to this study). Since fewer than 5 patients reached p≥0.5, the selection rule fell back to the top decile, flagging…
29 Sep 202621:13:45 UTC	safety_agent H2	completed	Claude · claude-sonnet-5 5.7 s	This is a pooled safety review across 307 treated patients with 1043 events (98 serious, 0 deaths), since the study is blinded and per-arm rates are not computed. The most frequent term is Nausea, 109 patients (35.5% inc…
29 Sep 202621:13:39 UTC	cdm_agent H1	completed	Claude · claude-sonnet-5 4.6 s	A CDM sweep of this Phase III NSCLC trial (317 subjects) ran 18 edit checks, with 3 firing: AE-001 "AE onset before first dose" (4 hits, P2), AE-005 "Serious AE without seriousness criteria" (1 hit, P2), and AE-007 "Dupl…
29 Sep 202621:13:34 UTC	monitoring_agent H2	completed	Claude · claude-sonnet-5 4.1 s	Across 15 sites (317 patients), centralized statistical monitoring flagged 2 outliers per the single-KRI rule (\|z\| ≥ 2.5, threshold 2.5). SITE006 (GBR): withdrawal rate 11% vs study mean 2%, z=3.01, exceeding threshold …
29 Sep 202621:13:30 UTC	recruitment_agent H2	completed	Claude · claude-sonnet-5 3.9 s	Overall enrollment is on pace: pace ratio 1.00 (317/450 accrued vs ~317.1 expected), with projected last-patient-in 2027-04-13 at the trailing 3-month rate of 20.6 consents/month, against a plan of 23.68/month. All 15/15…
29 Sep 202621:13:26 UTC	site_activation_agent H2	completed	Claude · claude-sonnet-5 4.2 s	All 15 sites are activated with contracts executed and readiness scored 1.0 each, with feasibility and regulatory submission both on file. Every site shows contract_days of 55, which is below both the contract negotiatio…
29 Sep 202621:13:22 UTC	protocol_agent H1	completed	Claude · claude-sonnet-5 4.1 s	The SPIRIT checklist lint of protocol v0.1-auto (pending_review) checked 61 items and found 42 gaps: 2 critical, 18 major, 22 minor, giving an amendment risk of 1.0 under the stated formula min(1, 0.04×minor + 0.08×major…
29 Sep 202621:13:18 UTC	feasibility_agent H1	completed	Claude · claude-sonnet-5 3.6 s	This trial scores 0.52 — feasible with mitigation. Demand is 1.5789 patients per site-month against a capacity of 1.7043 (observed accrual, replacing the assumed rate per Dombernowsky 2019), giving a burden of 0.9264, cl…
19 Sep 202608:59:53 UTC	tmf_agent H1	escalated Review task #08104d4c	Claude · claude-sonnet-5 4.6 s	This TMF self-audit against the DIA TMF Reference Model v3.2.1 (conduct stage) reports completeness of 0.65 against a threshold of 0.8, with 8 of 16 auditable artifacts fully present and 5 partial, triggering escalation …
19 Sep 202608:59:48 UTC	medical_writing_agent H1	escalated Review task #3fc277b5	Claude · claude-sonnet-5 12.9 s	This is a draft interim safety and status report, not a final CSR, following ICH E3 (CPMP/ICH/137/95). Of 317 randomized subjects, 43 completed (13.6%), 5 discontinued, and 269 remain ongoing against a target enrollment …
19 Sep 202608:59:36 UTC	biostats_agent H1	escalated Review task #2a3c5b8f	Claude · claude-sonnet-5 4.3 s	This is a blinded interim TLF run for this Phase III NSCLC study, per ICH E3 Section 14 (14.1 disposition/demographics, 14.2 efficacy, 14.3 safety). 7 tables/listings were generated covering disposition (14.1.1, 8 rows),…
19 Sep 202608:59:31 UTC	supply_agent partner	completed	Claude · claude-sonnet-5 4.2 s	The forecast projects 1769 blinded kits needed over 6 months, including the 15.0% kit buffer, covering 127 patients on treatment at 1.33 administrations/28 days, with 379.77 new-patient-months from 133 projected new pati…
19 Sep 202608:59:27 UTC	termination_watch_agent H2	escalated Review task #9d1c0817	Claude · claude-sonnet-5 4.0 s	Accrual is on track: 317 of 450 enrolled, pace ratio 102.5% of the pro-rata plan, trailing 3-month pace 22.72/month, projected LPI 2027-03-16, only 0.1 months ahead of the planned 2027-03-19 date. Implied early-terminati…
19 Sep 202608:59:23 UTC	retention_agent H2	escalated Review task #d0fac898	Claude · claude-sonnet-5 4.3 s	The retention model scored 269 active patients using a heuristic logistic function (coefficients described as "heuristic priors from the retention literature, not fitted to this study's outcomes"). Since no patient reach…
19 Sep 202608:59:19 UTC	safety_agent H2	escalated Review task #75744c32	Claude · claude-sonnet-5 21.6 s	This run triaged 11 new reports, all serious and all sent to physician review (5 with unassessed causality), with 11 SAE review tasks opened and 0 already pending. Study totals stand at 1043 events across 307 treated pat…
19 Sep 202608:58:57 UTC	cdm_agent H1	escalated Review task #320a6bd0	Claude · claude-sonnet-5 4.3 s	The CDM sweep of this Phase III NSCLC study (317 subjects) ran 18 edit checks; 3 fired: AE-001 (AE onset before first dose) ×4, AE-005 (serious AE without seriousness criteria) ×1, and AE-007 (duplicate AE record, determ…
19 Sep 202608:58:53 UTC	monitoring_agent H2	escalated Review task #94c4e7b2	Claude · claude-sonnet-5 4.0 s	Centralized statistical monitoring flagged 2 of 15 sites out of 317 patients, using 11 KRIs z-scored against the study population, per the TransCelerate RBM KRI set. SITE006 (GBR) triggered the single-KRI rule (\|z\| ≥ 2.5…
19 Sep 202608:58:49 UTC	recruitment_agent H2	escalated Review task #d1c930e4	Claude · claude-sonnet-5 4.9 s	Enrollment overall looks on track: pace ratio is 1.02 versus the pro-rata plan (317 of 450 accrued vs 309.3 expected to date), with trailing 3-month pace at 22.97/month and a projected last-patient-in date of 2027-03-14.…
19 Sep 202608:58:44 UTC	site_activation_agent H2	completed	Claude · claude-sonnet-5 4.4 s	All 15 sites are activation-ready with contracts executed (contract_days 55 each, versus benchmark contract negotiation median 33 d, Q3 77 d) and readiness scored 1.0 for every site. Days to FPI is 21 for all sites, well…
19 Sep 202608:58:40 UTC	protocol_agent H1	escalated Review task #2366277b	Claude · claude-sonnet-5 12.9 s	The auto-drafted protocol (v0.1-auto, claude-sonnet-5) used 11 of 11 fact groups but against the SPIRIT checklist, 61 items were checked and 42 gaps found: 2 critical, 18 major, 22 minor. Amendment risk is 1.0 (heuristic…
19 Sep 202608:58:27 UTC	feasibility_agent H1	completed	Claude · claude-sonnet-5 3.9 s	This trial is assessed as feasible with mitigation. Demand is 1.5789 patients per site-month against an observed capacity of 1.7043 per site-month, giving a burden of 0.9264 — close to capacity, as noted in the recommend…

Protocol versions 1

Every version stays on file. Read any version in full; edit the newest to save the next draft and re-run the protocol agent's SPIRIT lint on it.

v0.1-auto pending review protocol agent — 2026-09-19

Sites 15

Every site contracted for this study or with a participant on it — with this study's contract stage and enrollment. Open a site for its full monitoring picture.

Site	Country	Principal investigator	Site status	Contract	Participants	Risk
SITE001 (USA)	USA	Dr. Reyes	activated	executed 2025-08-25	21 enrolled · 21 on site	KRI 0.174
SITE002 (USA)	USA	Dr. Nolan	activated	executed 2025-08-17	22 enrolled · 22 on site	KRI 0.283
SITE003 (CAN)	CAN	Dr. Okafor	activated	executed 2025-07-30	22 enrolled · 22 on site	KRI 0.239
SITE004 (DEU)	DEU	Dr. Tanaka	activated	executed 2025-08-12	21 enrolled · 21 on site	KRI 0.139
SITE005 (FRA)	FRA	Dr. Muller	activated	executed 2025-07-23	21 enrolled · 21 on site	KRI 0.328
SITE006 (GBR)	GBR	Dr. Rossi	activated	executed 2025-07-23	19 enrolled · 19 on site	KRI 0.444
SITE007 (JPN)	JPN	Dr. Dubois	activated	executed 2025-07-30	19 enrolled · 19 on site	KRI 0.252
SITE008 (KOR)	KOR	Dr. Kim	activated	executed 2025-08-17	19 enrolled · 19 on site	KRI 0.299
SITE009 (AUS)	AUS	Dr. Novak	activated	executed 2025-08-22	20 enrolled · 20 on site	KRI 0.387
SITE010 (ESP)	ESP	Dr. Silva	activated	executed 2025-09-16	20 enrolled · 20 on site	KRI 0.381
SITE011 (ITA)	ITA	Dr. Jansen	activated	executed 2025-08-04	24 enrolled · 24 on site	KRI 0.306
SITE012 (BRA)	BRA	Dr. Kowalski	activated	executed 2025-08-03	26 enrolled · 26 on site	KRI 0.384
SITE013 (USA)	USA	Dr. Clarke	activated	executed 2025-08-07	23 enrolled · 23 on site	KRI 0.467
SITE014 (NLD)	NLD	Dr. Moreau	activated	executed 2025-09-09	19 enrolled · 19 on site	KRI 0.438
SITE015 (POL)	POL	Dr. Ito	activated	executed 2025-07-27	21 enrolled · 21 on site	KRI 0.308

Feasibility 1

13 countries (AUS, BRA, CAN, …) score 0.52 15 sites · 450 patients · 19 mo

Feasible with mitigation: demand 1.5789 per site-month against capacity 1.7043 (observed accrual) is burden 0.9264, close to capacity. Mitigation: hold the current footprint and monitor accrual monthly. 133 of 450 remain with 6.0 months left; at the observed pace they take about 5.2 months. ClinicalTrials.gov comparator (non-small cell lung cancer, phase 3, n=1025): 11.5% terminated, 3.1% for accrual, median enrollment 375.

Supply forecasts 2

6-month horizon: 1769 kits (450 predicted patients × 0.955 retention, 15% buffer)

6-month horizon: 1675 kits (439 predicted patients × 0.956 retention, 15% buffer)

Regulatory submissions 1

FDA · IND annual report pending_review

Study documents 10 files

Everything generated or filed for this study. Open a file to preview it as a PDF.