Trial · NCT03896503
Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs
NCT03896503, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2024-11-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs. Trials, record NCT03896503. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03896503
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs
- NCT number
- NCT03896503
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 104 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Extensive Stage Lung Small Cell Carcinoma, Extrapulmonary Small Cell Neuroendocrine Carcinoma, Limited Stage Lung Small Cell Carcinoma, Platinum-Resistant Lung Small Cell Carcinoma, Platinum-Sensitive Lung Small Cell Carcinoma, Recurrent Lung Small Cell Carcinoma
- Interventions
- Berzosertib, Biopsy Procedure, Biospecimen Collection, Computed Tomography, Topotecan Hydrochloride
- First posted
- 2019-04-01
- Last updated
- 2026-07-31
- Results first posted
- 2024-11-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) Reported With 80% Confidence Interval | From start of treatment to time of progression or death, whichever occurs first, assessed at 6 months after last participant has enrolled; up to 2 years for pulmonary cohort and up 31.5 months for Exploratory Cohort. | The combination of M6620 with topotecan will be compared to topotecan alone in participants with relapsed small cell lung cancer (SCLC). Kaplan-Meier curves and a one-tailed log-rank test will be the primary analysis methods. PFS is defined as the duration of time from start of treatment to time of progression or death. whichever occurs first. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, and/or the appearance of one or more new lesions. |
| Primary | Progression-free Survival (PFS) Reported With 95% Confidence Interval | From start of treatment to time of progression or death, whichever occurs first, assessed at 6 months after last participant has enrolled; up to 2 years for pulmonary cohort and up 31.5 months for Exploratory Cohort. | The combination of M6620 with topotecan will be compared to topotecan alone in participants with relapsed small cell lung cancer (SCLC). Kaplan-Meier curves and a one-tailed log-rank test will be the primary analysis methods. PFS is defined as the duration of time from start of treatment to time of progression or death. whichever occurs first. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, and/or the appearance of one or more new lesions. |
| Secondary | Objective Response Rate (ORR) | Up to 2 years | ORR is defined as percentage of participants who achieved either complete response (CR) or partial response (PR) as best response assessed using the revised Response Evaluation Criteria in Solid Tumors guideline (v 1.1). ORR percentage is calculated as the sum of the PR and CR rates, divided by the total number of participants who are evaluable for a response, multiplied by 100%. All participants included in the study must be assessed for response to treatment, even if there are major protocol treatment deviations or if they are ineligible. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the diameters of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive disease is at least a 20% increase in the sum of the diameters of target lesions. |
| Secondary | Overall Survival (OS) Reported With 80% Confidence Interval | Up to 2 years for pulmonary cohort and up 31.5 for Exploratory Cohort. | OS is defined as time from randomization to death, regardless of cause. |
| Secondary | Overall Survival (OS) Reported With 95% Confidence Interval | Up to 2 years for pulmonary cohort and up 31.5 for Exploratory Cohort | OS is defined as time from randomization to death, regardless of cause. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | Date treatment consent signed to date off study, an average of 801.3 days. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) Reported With 80% Confidence Interval | From start of treatment to time of progression or death, whichever occurs first, assessed at 6 months after last participant has enrolled; up to 2 years for pulmonary cohort and up 31.5 months for Exploratory Cohort. | Participants enrolled but not treated are not reported for this outcome measure. Six participants from the groups reported below were not evaluable for this outcome measure. Participants who have results reported were placed into categories per initial randomization. Exploratory cohort consists of participants with extrapulmonary disease and were not randomized to treatment. | Months | MEDIAN |
| PRIMARY | Progression-free Survival (PFS) Reported With 95% Confidence Interval | From start of treatment to time of progression or death, whichever occurs first, assessed at 6 months after last participant has enrolled; up to 2 years for pulmonary cohort and up 31.5 months for Exploratory Cohort. | Participants enrolled but not treated are not reported for this outcome measure. Six participants from the groups reported below were not evaluable for this outcome measure. Participants who have results reported were placed into categories per initial randomization. Exploratory cohort consists of participants with extrapulmonary disease and were not randomized to treatment. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | Up to 2 years | Participants enrolled but not treated are not reported for this outcome measure. Ten participants from the groups reported below were not evaluable for this outcome measure. Participants who have results reported were placed into categories per initial randomization. Exploratory cohort consists of participants with extrapulmonary disease and were not randomized to treatment. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) Reported With 80% Confidence Interval | Up to 2 years for pulmonary cohort and up 31.5 for Exploratory Cohort. | Participants enrolled but not treated are not reported for this outcome measure. Six participants from the groups reported below were not evaluable for this outcome measure. Participants who have results reported were placed into categories per initial randomization. Exploratory cohort consists of participants with extrapulmonary disease and were not randomized to treatment. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) Reported With 95% Confidence Interval | Up to 2 years for pulmonary cohort and up 31.5 for Exploratory Cohort | Months | MEDIAN | |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | Date treatment consent signed to date off study, an average of 801.3 days. | Participants enrolled but not treated are not reported for this outcome measure. Adverse events would not be monitored/assessed if the participant never received drug. Six participants (i.e., enrolled but not treated) from the groups reported below were not evaluable for this outcome measure. Participants who have results reported were placed into categories per initial randomization. Exploratory cohort consists of participants with extrapulmonary disease and were not randomized to treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) Reported With 80% Confidence Interval | Platinum Response - Sensitive: Topotecan Monotherapy | 5.5 | 80% Confidence Interval 2.6 to 6.0 | Months | |
| Progression-free Survival (PFS) Reported With 80% Confidence Interval | Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy | 4.4 | 80% Confidence Interval 3.4 to 5.5 | Months | |
| Progression-free Survival (PFS) Reported With 80% Confidence Interval | Platinum Response - Resistant: Topotecan Monotherapy | 2.1 | 80% Confidence Interval 1.3 to 3.0 | Months | |
| Progression-free Survival (PFS) Reported With 80% Confidence Interval | Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy | 2.7 | 80% Confidence Interval 2.0 to 4.0 | Months | |
| Progression-free Survival (PFS) Reported With 80% Confidence Interval | Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy | 1.5 | 80% Confidence Interval 1.4 to 1.8 | Months | |
| Progression-free Survival (PFS) Reported With 95% Confidence Interval | Platinum Response - Sensitive: Topotecan Monotherapy | 5.5 | 95% Confidence Interval 1.2 to 9.6 | Months | |
| Progression-free Survival (PFS) Reported With 95% Confidence Interval | Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy | 4.4 | 95% Confidence Interval 3.0 to 8.2 | Months | |
| Progression-free Survival (PFS) Reported With 95% Confidence Interval | Platinum Response - Resistant: Topotecan Monotherapy | 2.1 | 95% Confidence Interval 0.9 to 4.1 | Months | |
| Progression-free Survival (PFS) Reported With 95% Confidence Interval | Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy | 2.7 | 95% Confidence Interval 1.5 to 5.4 | Months | |
| Progression-free Survival (PFS) Reported With 95% Confidence Interval | Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy | 1.5 | 95% Confidence Interval 1.3 to 2.9 | Months |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow80
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Subgroup and Arm Enrollment | STARTED | Platinum Response - Sensitive: Topotecan Monotherapy | 10 | |
| Initial Subgroup and Arm Enrollment | STARTED | Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy | 20 | |
| Initial Subgroup and Arm Enrollment | STARTED | Platinum Response - Sensitive: Enrolled But Not Treated | 10 | |
| Initial Subgroup and Arm Enrollment | STARTED | Platinum Response - Resistant: Topotecan Monotherapy | 11 | |
| Initial Subgroup and Arm Enrollment | STARTED | Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy | 23 | |
| Initial Subgroup and Arm Enrollment | STARTED | Platinum Response - Resistant: Enrolled But Not Treated | 9 | |
| Initial Subgroup and Arm Enrollment | STARTED | Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy | 18 | |
| Initial Subgroup and Arm Enrollment | STARTED | Exploratory Cohort: Enrolled But Not Treated | 3 | |
| Initial Subgroup and Arm Enrollment | Not Treated | Platinum Response - Sensitive: Topotecan Monotherapy | 1 | |
| Initial Subgroup and Arm Enrollment | Not Treated | Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy | 0 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 participant flowAdverse events2,072
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Platinum Response - Sensitive: Topotecan Monotherapy | 1 | 9 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy | 0 | 20 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Platinum Response - Resistant: Topotecan Monotherapy | 0 | 11 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy | 0 | 20 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy | 2 | 16 | 2 |
| other | Abdominal distension | Gastrointestinal disorders | Platinum Response - Sensitive: Topotecan & M6620 Combination Therapy -Cross-over From Cohort 1 Arm I | 1 | 5 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Platinum Response -Resistant: Topotecan & M6620 Combination Therapy - Cross-over From Cohort 2 Arm 1 | 0 | 6 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Platinum Response - Sensitive: Topotecan Monotherapy | 1 | 9 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy | 5 | 20 | 9 |
| other | Abdominal pain | Gastrointestinal disorders | Platinum Response - Resistant: Topotecan Monotherapy | 3 | 11 | 3 |
1 to 10 of 2,072Source ClinicalTrials.gov
See all 2,072 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Platinum Response - Sensitive: Topotecan Monotherapy | 9 | 9 |
| Total, all-cause mortality | Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy | 19 | 20 |
| Total, all-cause mortality | Platinum Response - Resistant: Topotecan Monotherapy | 11 | 11 |
| Total, all-cause mortality | Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy | 19 | 20 |
| Total, all-cause mortality | Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy | 15 | 16 |
| Total, all-cause mortality | Platinum Response - Sensitive: Topotecan & M6620 Combination Therapy -Cross-over From Cohort 1 Arm I | 5 | 5 |
| Total, all-cause mortality | Platinum Response -Resistant: Topotecan & M6620 Combination Therapy - Cross-over From Cohort 2 Arm 1 | 6 | 6 |
| Total, other adverse events | Platinum Response - Sensitive: Topotecan Monotherapy | 8 | 9 |
| Total, other adverse events | Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy | 20 | 20 |
| Total, other adverse events | Platinum Response - Resistant: Topotecan Monotherapy | 11 | 11 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| ZIABC011078 | Phase 0-1 Clinical Trials | DOROSHOW, JAMES | DIVISION OF BASIC SCIENCES - NCI | NATIONAL CANCER INSTITUTE | 2009 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03896503
GET https://conductscience.org/api/trials/v1/NCT03896503/results?page=2