This completed Phase II sarcoma study (INNO-206 vs doxorubicin) accrued 126 of 105 planned (120.0% attainment) between 2012-01-11 and 2013-07-27, finishing 1.5 months ahead of the 18-month plan with last patient in on 2013-05-25 versus a planned 2013-07-11 — accrual pace was not a concern (pace ratio 1.2 vs threshold 0.6).
The screening estimate of early-termination probability is 23.2%, based on a base rate of 22.7% (Zhang & DuBois 2023, Cancer Med 12:5517–5525), adjusted for phase II (OR 1.58) and a 7-country international footprint (OR 0.65, protective). No ClinicalTrials.gov comparator was available for this indication/phase.
One flag was raised at close-out: Serious-AE density 63.5% (80 serious AEs / 126 enrolled; threshold 30.0%, an escalation-pressure proxy), alongside a 52.4% death rate and 66 deaths recorded.
No review task was opened, as the study is already completed. Per Lièvre et al. 2001 (BMJ 322:603–605), only efficacy, safety, or feasibility can justify termination — this remains a human decision.
This completed Phase II sarcoma study (INNO-206 vs doxorubicin) accrued 126 of 105 planned (120.0% attainment) between 2012-01-11 and 2013-07-27, finishing 1.5 months ahead of the 18-month plan with last patient in on 2013-05-25 versus a planned 2013-07-11 — accrual pace was not a concern (pace ratio 1.2 vs threshold 0.6).
The screening estimate of early-termination probability is 23.2%, based on a base rate of 22.7% (Zhang & DuBois 2023, Cancer Med 12:5517–5525), adjusted for phase II (OR 1.58) and a 7-country international footprint (OR 0.65, protective). No ClinicalTrials.gov comparator was available for this indication/phase.
One flag was raised at close-out: Serious-AE density 63.5% (80 serious AEs / 126 enrolled; threshold 30.0%, an escalation-pressure proxy), alongside a 52.4% death rate and 66 deaths recorded.
No review task was opened, as the study is already completed. Per Lièvre et al. 2001 (BMJ 322:603–605), only efficacy, safety, or feasibility can justify termination — this remains a human decision.
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 — accrual=%{"accrued" => 126, "as_of" => "2014-12-15", "at
Evidence
Accrual pace threshold
0.60
As of
2014-12-15
Deterministic summary
Retrospective on completed study "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": Accrued 126 of 105 (120.0% attainment) between 2012-01-11 and 2013-07-27 against a 18-month plan; final pace ratio 120.0% of pro-rata; last patient in 2013-05-25, 1.5 months ahead of plan. Implied early-termination probability 23.2% (base rate 22.7% from Zhang & DuBois 2023, Cancer Med 12:5517–5525 (8,687 oncology trials, 22.7% terminated); phase II OR 1.58, footprint 7 countries OR 0.65; Zhang & DuBois 2023, Cancer Med 12:5517–5525). No ClinicalTrials.gov comparator for Soft-tissue sarcoma phase II in the snapshot. Close-out observations: Serious-AE density 63.5% (80 serious AEs / 126 enrolled; threshold 30.0%, escalation-pressure proxy). No task — the study is completed. Termination is a human decision — only efficacy, safety, or feasibility justify it (Lièvre et al. 2001, BMJ 322:603–605).
Flags
1
Mode
retrospective
Review opened
no
Review pending
no
Risk level
—
Status
completed
Accrual
Accrued
126
As of
2014-12-15
Attainment
1.20
Available
yes
Elapsed months
35.16
Expected to date
105.00
First consent on
2012-01-11
Grace window
no
Last consent on
2013-07-27
Months vs plan
-1.50
Overall per month
3.58
Pace below threshold
no
Pace ratio
1.20
Pace threshold
0.60
Plan complete
yes
Plan months
18
Planned lpi on
2013-07-11
Projected lpi on
2013-05-25
Projection basis
target reached
Start on
2012-01-11
Target
105
Trailing 3m per month
0.00
Undated consents
0
Table
Consents
Cumulative
Month
Partial
Plan
2
2
1
no
6
0
2
2
no
12
2
4
3
no
18
2
6
4
no
23
3
9
5
no
29
7
16
6
no
35
8
24
7
no
41
5
29
8
no
47
5
34
9
no
53
10
44
10
no
58
8
52
11
no
64
6
58
12
no
70
8
66
13
no
76
8
74
14
no
82
14
88
15
no
88
10
98
16
no
93
10
108
17
no
99
10
118
18
no
105
8
126
19
no
105
0
126
20
no
105
0
126
21
no
105
0
126
22
no
105
0
126
23
no
105
0
126
24
no
105
0
126
25
no
105
0
126
26
no
105
0
126
27
no
105
0
126
28
no
105
0
126
29
no
105
0
126
30
no
105
0
126
31
no
105
0
126
32
no
105
0
126
33
no
105
0
126
34
no
105
0
126
35
no
105
0
126
36
yes
105
Citations
Zhang & DuBois 2023, Cancer Med 12:5517–5525 — 8,687 oncology trials: 22.7% terminated; poor accrual 34.5% of terminations; ORs non-industry 4.56, multiple 3.87, government 2.68, phase 2 1.58, phase 4 2.41, supportive care 1.71, international 0.65
Lièvre et al. 2001, BMJ 322:603–605 — only efficacy, safety or feasibility legitimize stopping; sponsor-independent oversight
Lee KM et al. 2026 (OCTAVE), Stat Med 45:e70449 — interim analyses pre-specified at recruitment milestones with simulation-validated operating characteristics
ClinicalTrials.gov API v2 comparator snapshot (public domain)
Comparator
Matched
no
Note
No ClinicalTrials.gov comparator for Soft-tissue sarcoma phase II in the snapshot
Zhang & DuBois 2023, Cancer Med 12:5517–5525 (8,687 oncology trials, 22.7% terminated)
High threshold
0.50
Implied probability
0.23
Logit
-1.20
Method
logit = ln(base/(1-base)) + Σ ln(OR_i); ORs from a multivariable model of accrual-driven termination (Zhang & DuBois 2023, Cancer Med 12:5517–5525), combined assuming independence — a screening estimate, not a calibrated prediction
Contributors
Basis
Citation
Factor
Log odds
Odds ratio
Value
phase 2 vs phase 3
Zhang & DuBois 2023, Cancer Med 12:5517–5525
phase
0.46
1.58
II
international footprint vs single-country (protective)
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 threshold of 0.6. The screening model gives an implied early-termination probability of 16.7%, below the base rate of 23.5% (ClinicalTrials.gov NSCLC phase 3, 118/501 closed trials terminated), aided by footprint (13 countries, OR 0.65, Zhang & DuBois 2023). One flag was raised: Serious-AE density 30.9% (98 serious AEs / 317 enrolled) versus threshold 30.0%, an escalation-pressure proxy. Comparator data (Zhang & DuBois 2023) show 32 of terminations (27.1%) were accrual-related, with median enrollment 153.5 for terminated vs 438 for completed trials. A human assessment is already pending, so no new review was opened. The human is asked to review the serious-AE density flag alongside the pending assessment.
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 threshold of 0.6. The screening model gives an implied early-termination probability of 16.7%, below the base rate of 23.5% (ClinicalTrials.gov NSCLC phase 3, 118/501 closed trials terminated), aided by footprint (13 countries, OR 0.65, Zhang & DuBois 2023). One flag was raised: Serious-AE density 30.9% (98 serious AEs / 317 enrolled) versus threshold 30.0%, an escalation-pressure proxy. Comparator data (Zhang & DuBois 2023) show 32 of terminations (27.1%) were accrual-related, with median enrollment 153.5 for terminated vs 438 for completed trials. A human assessment is already pending, so no new review was opened. The human is asked to review the serious-AE density flag alongside the pending assessment.
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=%{"accrued" => 317, "as_of" => "2026-09-19", "attainment" => 0.704, "available" => true, "elapsed_months" => 13.06, "expec
Evidence
Accrual pace threshold
0.60
As of
2026-09-19
Deterministic summary
Termination-risk surveillance 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": 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. 1 flag(s) refreshed: Serious-AE density 30.9% (98 serious AEs / 317 enrolled; threshold 30.0%, escalation-pressure proxy). A human assessment is already pending, so no second task was opened. Termination is a human decision — only efficacy, safety, or feasibility justify it (Lièvre et al. 2001, BMJ 322:603–605).
Flags
1
Mode
surveillance
Review opened
no
Review pending
yes
Risk level
medium
Status
active
Accrual
Accrued
317
As of
2026-09-19
Attainment
0.70
Available
yes
Elapsed months
13.06
Expected to date
309.30
First consent on
2025-08-18
Grace window
no
Last consent on
2026-09-17
Months to lpi
5.90
Months vs plan
-0.10
Overall per month
24.27
Pace below threshold
no
Pace ratio
1.02
Pace threshold
0.60
Plan complete
yes
Plan months
19
Planned lpi on
2027-03-19
Projected lpi on
2027-03-16
Projection basis
trailing 3-month pace
Start on
2025-08-18
Target
450
Trailing 3m per month
22.72
Undated consents
0
Table
Consents
Cumulative
Month
Partial
Plan
21
21
1
no
24
20
41
2
no
47
25
66
3
no
71
23
89
4
no
95
24
113
5
no
118
31
144
6
no
142
21
165
7
no
166
24
189
8
no
189
30
219
9
no
213
26
245
10
no
237
24
269
11
no
261
23
292
12
no
284
25
317
13
no
308
0
317
14
yes
332
Citations
Zhang & DuBois 2023, Cancer Med 12:5517–5525 — 8,687 oncology trials: 22.7% terminated; poor accrual 34.5% of terminations; ORs non-industry 4.56, multiple 3.87, government 2.68, phase 2 1.58, phase 4 2.41, supportive care 1.71, international 0.65
Lièvre et al. 2001, BMJ 322:603–605 — only efficacy, safety or feasibility legitimize stopping; sponsor-independent oversight
Lee KM et al. 2026 (OCTAVE), Stat Med 45:e70449 — interim analyses pre-specified at recruitment milestones with simulation-validated operating characteristics
ClinicalTrials.gov API v2 comparator snapshot (public domain)
Comparator
Accrual terminated
32
Accrual terminated rate of terminated
0.27
Completed
383
Fetched at
2026-09-19T08:06:16Z
Indication
Non-Small Cell Lung Cancer
Key
nsclc_phase3
Live check
—
Matched
yes
Median enrollment completed
438
Median enrollment terminated
153.50
Phase
3
Source
snapshot
Terminated
118
Terminated rate
0.12
Terminated rate of closed
0.24
Total trials
1025
Examples
Completion date
Enrollment
Nct id
Sponsor class
Start date
Title
Why stopped
—
158
NCT00003803
NETWORK
1999-02
Chemotherapy Plus Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Cannot Be Surgically Removed
low accrual
2004-02
10
NCT00032084
NETWORK
2002-01
S0002 - A Program to Quit Smoking With or Without Bupropion in Treating Patients With Stage I or II Non-Small Cell Lung Cancer Who Have Undergone Surgery
This study was closed early due to poor accrual
—
598
NCT00091156
NETWORK
2004-05
Gefitinib After Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
low accrual
—
19
NCT00113386
NETWORK
2005-04
Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer
This study terminated early due to low accrual.
2007-08
490
NCT00234468
INDUSTRY
2004-01
Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC
logit = ln(base/(1-base)) + Σ ln(OR_i); ORs from a multivariable model of accrual-driven termination (Zhang & DuBois 2023, Cancer Med 12:5517–5525), combined assuming independence — a screening estimate, not a calibrated prediction
Contributors
Basis
Citation
Factor
Log odds
Odds ratio
Value
international footprint vs single-country (protective)
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-termination probability is 16.7%, versus a base rate of 23.5% (ClinicalTrials.gov NSCLC phase 3 snapshot, 118/501 closed trials terminated), adjusted for the study's international footprint of 13 countries (OR 0.65, Zhang & DuBois 2023, Cancer Med 12:5517–5525). Comparator data show 32 of 118 terminated trials (27.1%) stopped for accrual, with median enrollment 153.5 (terminated) vs 438 (completed). One flag was raised: Serious-AE density 30.9% (98/317) versus the 30.0% threshold, an escalation-pressure proxy. This opened a medium-risk assess_termination_risk task. A human reviewer is asked to decide whether the elevated serious-AE density warrants further safety review or action.
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-termination probability is 16.7%, versus a base rate of 23.5% (ClinicalTrials.gov NSCLC phase 3 snapshot, 118/501 closed trials terminated), adjusted for the study's international footprint of 13 countries (OR 0.65, Zhang & DuBois 2023, Cancer Med 12:5517–5525). Comparator data show 32 of 118 terminated trials (27.1%) stopped for accrual, with median enrollment 153.5 (terminated) vs 438 (completed). One flag was raised: Serious-AE density 30.9% (98/317) versus the 30.0% threshold, an escalation-pressure proxy. This opened a medium-risk assess_termination_risk task. A human reviewer is asked to decide whether the elevated serious-AE density warrants further safety review or action.
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=%{"accrued" => 317, "as_of" => "2026-09-19", "attainment" => 0.704, "available" => true, "elapsed_months" => 13.06, "expec
Evidence
Accrual pace threshold
0.60
As of
2026-09-19
Deterministic summary
Termination-risk surveillance 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": 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. 1 flag(s): Serious-AE density 30.9% (98 serious AEs / 317 enrolled; threshold 30.0%, escalation-pressure proxy). Opened a medium-risk assess_termination_risk task. Termination is a human decision — only efficacy, safety, or feasibility justify it (Lièvre et al. 2001, BMJ 322:603–605).
Flags
1
Mode
surveillance
Review opened
yes
Review pending
no
Risk level
medium
Status
active
Accrual
Accrued
317
As of
2026-09-19
Attainment
0.70
Available
yes
Elapsed months
13.06
Expected to date
309.30
First consent on
2025-08-18
Grace window
no
Last consent on
2026-09-17
Months to lpi
5.90
Months vs plan
-0.10
Overall per month
24.27
Pace below threshold
no
Pace ratio
1.02
Pace threshold
0.60
Plan complete
yes
Plan months
19
Planned lpi on
2027-03-19
Projected lpi on
2027-03-16
Projection basis
trailing 3-month pace
Start on
2025-08-18
Target
450
Trailing 3m per month
22.72
Undated consents
0
Table
Consents
Cumulative
Month
Partial
Plan
21
21
1
no
24
20
41
2
no
47
25
66
3
no
71
23
89
4
no
95
24
113
5
no
118
31
144
6
no
142
21
165
7
no
166
24
189
8
no
189
30
219
9
no
213
26
245
10
no
237
24
269
11
no
261
23
292
12
no
284
25
317
13
no
308
0
317
14
yes
332
Citations
Zhang & DuBois 2023, Cancer Med 12:5517–5525 — 8,687 oncology trials: 22.7% terminated; poor accrual 34.5% of terminations; ORs non-industry 4.56, multiple 3.87, government 2.68, phase 2 1.58, phase 4 2.41, supportive care 1.71, international 0.65
Lièvre et al. 2001, BMJ 322:603–605 — only efficacy, safety or feasibility legitimize stopping; sponsor-independent oversight
Lee KM et al. 2026 (OCTAVE), Stat Med 45:e70449 — interim analyses pre-specified at recruitment milestones with simulation-validated operating characteristics
ClinicalTrials.gov API v2 comparator snapshot (public domain)
Comparator
Accrual terminated
32
Accrual terminated rate of terminated
0.27
Completed
383
Fetched at
2026-09-19T08:06:16Z
Indication
Non-Small Cell Lung Cancer
Key
nsclc_phase3
Live check
—
Matched
yes
Median enrollment completed
438
Median enrollment terminated
153.50
Phase
3
Source
snapshot
Terminated
118
Terminated rate
0.12
Terminated rate of closed
0.24
Total trials
1025
Examples
Completion date
Enrollment
Nct id
Sponsor class
Start date
Title
Why stopped
—
158
NCT00003803
NETWORK
1999-02
Chemotherapy Plus Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Cannot Be Surgically Removed
low accrual
2004-02
10
NCT00032084
NETWORK
2002-01
S0002 - A Program to Quit Smoking With or Without Bupropion in Treating Patients With Stage I or II Non-Small Cell Lung Cancer Who Have Undergone Surgery
This study was closed early due to poor accrual
—
598
NCT00091156
NETWORK
2004-05
Gefitinib After Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
low accrual
—
19
NCT00113386
NETWORK
2005-04
Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer
This study terminated early due to low accrual.
2007-08
490
NCT00234468
INDUSTRY
2004-01
Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC
logit = ln(base/(1-base)) + Σ ln(OR_i); ORs from a multivariable model of accrual-driven termination (Zhang & DuBois 2023, Cancer Med 12:5517–5525), combined assuming independence — a screening estimate, not a calibrated prediction
Contributors
Basis
Citation
Factor
Log odds
Odds ratio
Value
international footprint vs single-country (protective)