Kits required over the horizon from observed dosing, accrual and discontinuation (partner IRT).
Escalates: Nothing — purely operational. The kit forecast is handed to the IRT/RTSM partner, where humans act on it
— to the IRT/RTSM partner (integration boundary).
This study is completed, so the report is retrospective rather than a forward forecast. Across the trial, 573 IP kits (Aldoxorubicin (INNO-206) and Doxorubicin) were dispensed to 123 patients, averaging 4.7 kits per patient. Dosing was observed at 1.33 administrations per 28 days, with median doses of 350.0 mg/m2 (Aldoxorubicin) and 75.0 mg/m2 (Doxorubicin). The observed monthly stop rate was 38.7%, giving a retention rate of 0.613 (123 stops over 317.7 patient-months). Of the 573 kits dispensed, 45 kits (7.9%) went to patients who later withdrew, serving as a waste proxy. No forward-looking forecast was generated since the study status is "completed" and there are 0 patients on treatment. No thresholds were breached and no review task was opened in this summary.
This study is completed, so the report is retrospective rather than a forward forecast. Across the trial, 573 IP kits (Aldoxorubicin (INNO-206) and Doxorubicin) were dispensed to 123 patients, averaging 4.7 kits per patient. Dosing was observed at 1.33 administrations per 28 days, with median doses of 350.0 mg/m2 (Aldoxorubicin) and 75.0 mg/m2 (Doxorubicin). The observed monthly stop rate was 38.7%, giving a retention rate of 0.613 (123 stops over 317.7 patient-months). Of the 573 kits dispensed, 45 kits (7.9%) went to patients who later withdrew, serving as a waste proxy. No forward-looking forecast was generated since the study status is "completed" and there are 0 patients on treatment. No thresholds were breached and no review task was opened in this summary.
Input: A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma — as_of="2026-09-29", assumptions=["Kit buffer of 15.0% ap
Evidence
As of
2026-09-29
Blinded
no
Deterministic summary
Study completed — retrospective: 573 IP kits (Aldoxorubicin (INNO-206)/Doxorubicin) dispensed to 123 patients, 4.7 kits per patient; monthly stop rate 38.7% (retention 0.613). 45 kits (7.9%) went to patients who later withdrew (waste proxy). No forecast written.
Dosing mode
observed
Enrolled to date
126
Horizon months
6
Ip administrations per 28d
1.33
Kit buffer
0.15
Kit definition
one administration (dispensing record) of investigational product
Kit label
IP kits
Kits per patient month
1.45
Mode
retrospective
On treatment
0
Predicted retention rate
0.61
Source
partner:irt-rtsm
Target enrollment
105
Undosed active
0
Assumptions
Kit buffer of 15.0% applied on top of modeled demand.
Per-site weeks of cover assume a depot of 2 months' current burn; stock-on-hand comes from the IRT/RTSM partner.
Sites with nobody dosing yet are assumed to receive initial stock from the IRT partner at activation and are not scored for cover.
New patients accrue linearly over the horizon (each contributes half a month of dosing in the month of entry).
Commercial supply
No evidence recorded for this run.
Discontinuation
Basis
observed
Monthly stop rate
0.39
Patient months
317.70
Patients dosed
123
Retention rate
0.61
Stops
123
Dosing model
Aldoxorubicin (inno-206)
Administrations
404
Administrations per 28d
1.33
Basis
median gap between administrations 21.0 d (321 gaps)
Class
ip
Dose unit
mg/m2
Median dose
350.00
Patients
83
Doxorubicin
Administrations
169
Administrations per 28d
1.33
Basis
median gap between administrations 21.0 d (129 gaps)
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. This reflects 122 patients on treatment at 1.33 administrations/28 days, accrual of 20.33 patients/month (61 consents in the trailing 90 days), and an observed monthly stop rate of 4.4% (retention 0.956). All 15 sites are activated and none are flagged at_risk; the tightest site is SITE012 (BRA) with 6.3 weeks of cover, above any at-risk threshold implied here. Escalation shows task_opened as false and tight_sites empty, so no review task was generated. No human decision is required at this time based on the evidence provided.
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. This reflects 122 patients on treatment at 1.33 administrations/28 days, accrual of 20.33 patients/month (61 consents in the trailing 90 days), and an observed monthly stop rate of 4.4% (retention 0.956). All 15 sites are activated and none are flagged at_risk; the tightest site is SITE012 (BRA) with 6.3 weeks of cover, above any at-risk threshold implied here. Escalation shows task_opened as false and tight_sites empty, so no review task was generated. No human decision is required at this time based on the evidence provided.
Input: A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer — accrual=%{"capped_at_target" => false, "consents_trailing_90d" => 61, "per_month" => 20.33, "projected_new_patients" => 122.0}, as
Evidence
As of
2026-09-29
Blinded
yes
Deterministic summary
Forecast 1675 blinded kits (PLACEBO/TORIVUMAB) over 6 months incl. 15.0% buffer — 122 patients on treatment at 1.33 administrations/28 d, accrual 20.33/month, monthly stop rate 4.4% (retention 0.956). Tightest site: SITE012 (BRA) at 6.3 weeks of cover. New forecast recorded (previous 1769 kits, -5.3%). Handed to partner:irt-rtsm.
Dosing mode
observed
Enrolled to date
317
Horizon months
6
Ip administrations per 28d
1.33
Kit buffer
0.15
Kit definition
one administration (dispensing record) of investigational product
Kit label
blinded kits
Kits per patient month
1.45
Kits required
1675
Mode
prospective
On treatment
122
Predicted enrollment
439
Predicted retention rate
0.96
Source
partner:irt-rtsm
Target enrollment
450
Undosed active
9
Accrual
Capped at target
no
Consents trailing 90d
61
Per month
20.33
Projected new patients
122.00
Assumptions
Kit buffer of 15.0% applied on top of modeled demand.
Per-site weeks of cover assume a depot of 2 months' current burn; stock-on-hand comes from the IRT/RTSM partner.
Sites with nobody dosing yet are assumed to receive initial stock from the IRT partner at activation and are not scored for cover.
New patients accrue linearly over the horizon (each contributes half a month of dosing in the month of entry).
Commercial supply
Carboplatin
Administrations
1488
Administrations per 28d
1.33
Dose unit
mg
Median dose
520.00
Patients
307
Pemetrexed
Administrations
2398
Administrations per 28d
1.33
Dose unit
mg/m2
Median dose
925.00
Patients
307
Demand
Base kits
1456.31
Buffer
0.15
Current patient months
656.05
Kits required
1675
New patient months
348.63
Discontinuation
Basis
observed
Monthly stop rate
0.04
Patient months
1597.10
Patients dosed
307
Retention rate
0.96
Stops
70
Dosing model
Carboplatin
Administrations
1488
Administrations per 28d
1.33
Basis
median gap between administrations 21.0 d (1181 gaps)
Class
backbone
Dose unit
mg
Median dose
520.00
Patients
307
Pemetrexed
Administrations
2398
Administrations per 28d
1.33
Basis
median gap between administrations 21.0 d (2091 gaps)
Class
backbone
Dose unit
mg/m2
Median dose
925.00
Patients
307
Placebo
Administrations
718
Administrations per 28d
1.33
Basis
median gap between administrations 21.0 d (566 gaps)
Class
placebo
Dose unit
mg
Median dose
0.00
Patients
152
Torivumab
Administrations
770
Administrations per 28d
1.33
Basis
median gap between administrations 21.0 d (615 gaps)
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 patients (accrual 22.17/month, capped at the 450-patient target) plus 681.25 current patient-months. Monthly stop rate is 4.5% (retention 0.955), based on observed data from 69 stops among 307 dosed patients. The tightest site is SITE014 (NLD) at 6.0 weeks of cover, with a depot assumption of 2 months' current burn; no site is flagged at_risk, and escalation shows task_opened: false with no tight_sites listed. This is the first recorded forecast for this study (previous_enrollment and previous_kits are null). No threshold breach or escalation is indicated, so no human decision is required at this time.
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 patients (accrual 22.17/month, capped at the 450-patient target) plus 681.25 current patient-months. Monthly stop rate is 4.5% (retention 0.955), based on observed data from 69 stops among 307 dosed patients. The tightest site is SITE014 (NLD) at 6.0 weeks of cover, with a depot assumption of 2 months' current burn; no site is flagged at_risk, and escalation shows task_opened: false with no tight_sites listed. This is the first recorded forecast for this study (previous_enrollment and previous_kits are null). No threshold breach or escalation is indicated, so no human decision is required at this time.
Input: A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer — accrual=%{"capped_at_target" => true, "consents_trailing_90d" => 68, "per_month" => 22.17, "projected_new_patients" => 133.0}, as_
Evidence
As of
2026-09-19
Blinded
yes
Deterministic summary
Forecast 1769 blinded kits (PLACEBO/TORIVUMAB) over 6 months incl. 15.0% buffer — 127 patients on treatment at 1.33 administrations/28 d, accrual 22.17/month, monthly stop rate 4.5% (retention 0.955). Tightest site: SITE014 (NLD) at 6.0 weeks of cover. First forecast recorded for this study. Handed to partner:irt-rtsm.
Dosing mode
observed
Enrolled to date
317
Horizon months
6
Ip administrations per 28d
1.33
Kit buffer
0.15
Kit definition
one administration (dispensing record) of investigational product
Kit label
blinded kits
Kits per patient month
1.45
Kits required
1769
Mode
prospective
On treatment
127
Predicted enrollment
450
Predicted retention rate
0.96
Source
partner:irt-rtsm
Target enrollment
450
Undosed active
9
Accrual
Capped at target
yes
Consents trailing 90d
68
Per month
22.17
Projected new patients
133.00
Assumptions
Projected accrual capped at the remaining 133 of the 450-patient target.
Kit buffer of 15.0% applied on top of modeled demand.
Per-site weeks of cover assume a depot of 2 months' current burn; stock-on-hand comes from the IRT/RTSM partner.
Sites with nobody dosing yet are assumed to receive initial stock from the IRT partner at activation and are not scored for cover.
New patients accrue linearly over the horizon (each contributes half a month of dosing in the month of entry).
Commercial supply
Carboplatin
Administrations
1488
Administrations per 28d
1.33
Dose unit
mg
Median dose
520.00
Patients
307
Pemetrexed
Administrations
2398
Administrations per 28d
1.33
Dose unit
mg/m2
Median dose
925.00
Patients
307
Demand
Base kits
1537.97
Buffer
0.15
Current patient months
681.25
Kits required
1769
New patient months
379.77
Discontinuation
Basis
observed
Monthly stop rate
0.05
Patient months
1521.20
Patients dosed
307
Retention rate
0.96
Stops
69
Dosing model
Carboplatin
Administrations
1488
Administrations per 28d
1.33
Basis
median gap between administrations 21.0 d (1181 gaps)
Class
backbone
Dose unit
mg
Median dose
520.00
Patients
307
Pemetrexed
Administrations
2398
Administrations per 28d
1.33
Basis
median gap between administrations 21.0 d (2091 gaps)
Class
backbone
Dose unit
mg/m2
Median dose
925.00
Patients
307
Placebo
Administrations
718
Administrations per 28d
1.33
Basis
median gap between administrations 21.0 d (566 gaps)
Class
placebo
Dose unit
mg
Median dose
0.00
Patients
152
Torivumab
Administrations
770
Administrations per 28d
1.33
Basis
median gap between administrations 21.0 d (615 gaps)