Trial · NCT03737994
Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer
NCT03737994, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2023-11-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer. Trials, record NCT03737994. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03737994
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer
- NCT number
- NCT03737994
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Lung Non-Squamous Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
- Interventions
- Alectinib, Brigatinib, Carboplatin, Ceritinib, Cisplatin, Crizotinib, Ensartinib, Lorlatinib, Pemetrexed
- First posted
- 2018-11-13
- Last updated
- 2026-04-23
- Results first posted
- 2023-11-21
- Limitations and caveats
This study stopped accrual early due to unmet targeted accrual goals with 10 subjects randomized out of 660 planned. Study assessments and data collection continued only for those participants still receiving study treatment and ceased at treatment completion.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR), Per Investigator Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria | Baseline to 24 weeks | ORR= number of subjects with best overall response (BOR) of complete or partial response (CR, PR) divided by number of evaluable subjects. BOR= best response recorded from start of treatment to first progression (PD)/new anticancer therapy, otherwise last follow-up. * CR: disappearance of target and non-target lesions; no new lesions; pathological lymph nodes \< 10mm. * PR: 30% decrease in target lesions; non-target lesions not progressed or not evaluated; no new lesions. * PD: 20% increase of target lesions and/or new lesion(s). ORR was to be compared using Fisher's exact test within each ALK inhibitor treatment arm (each mutation vs. no mutation) and also within the subset of subjects with no mutation comparing each experimental arm vs. pemetrexed. Due to early accrual closure (few subjects), only the number of subjects with BOR of CR or PR are provided, by mutation, no statistical testing. Analysis was to occur after each patient was potentially followed ≥ 24 weeks. |
| Secondary | Progression-free Survival (PFS), Per Investigator Assessment Using RECIST v1.1 Criteria | Baseline to the date of the first disease progression / progressive disease, death, or last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months. | Progression-free survival time is defined as the time from second step registration to the date of the first disease progression / progressive disease (PD), death, or last known follow-up (censored). Progressive disease is defined as a 20% increase of target lesions and/or new lesion(s). Percentage of participants progression-free at a given time (PFS) was to be estimated by the Kaplan-Meier method. Median PFS and PFS at specific time points was to be reported, with 95% confidence intervals, for each mutation (or no mutation)/regimen combination. Due to early accrual closure resulting in few participants, only the number of participants who progressed or died, by mutation, with no statistical testing. |
| Secondary | Duration of Overall Response, Per Investigator Assessment Using RECIST v1.1 | Baseline to the date of the first disease progression / progressive disease, death, or last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months. | Duration of overall response (DOR) is defined as the time from the first occurrence of a documented BOR of CR or PR to the first date of recorded disease progression (PD) or death from any cause (whichever occurs first). BOR is the best response recorded from the start of treatment to first progression (PD)/new anticancer therapy, otherwise last follow-up. * CR: disappearance of target and non-target lesions; no new lesions; pathological lymph nodes \< 10mm. * PR: 30% decrease in target lesions; non-target lesions not progressed or not evaluated; no new lesions. * PD: 20% increase of target lesions and/or new lesion(s). Median DOR was to be estimated, with 95% confidence intervals, for each mutation/regimen combination using the Kaplan-Meier method. Due to early accrual closure resulting in few subjects, only the mean and range DOR are provided, by mutation, and no statistical testing was done. |
| Secondary | Overall Survival (OS) | Baseline to the date of death or last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months. | Survival time is defined as the time from second step registration to the date of death, or last known follow-up (censored). Percentage of participants alive at a given time (OS) was to be estimated by the Kaplan-Meier method. Median OS and OS at specific time points was to be reported, with 95% confidence intervals, for each mutation/regimen combination. Due to early accrual closure resulting in few patients, only the number of participants who died are provided, by mutation, and no statistical testing was done. |
| Secondary | Intracranial Objective Response Rate, Per Investigator Assessment Using RECIST v1.1 | Baseline to 24 weeks | Intracranial objective response rate (IORR) is defined as the number of participants with central nervous system (CNS) metastasis complete or partial response (CR, PR) divided by the number of evaluable participants with baseline CNS metastasis and no prior CNS radiation therapy. Participants who required additional treatment (for their non-cranial systemic disease) would be considered as non-responders (if they have not previously had an intracranial response). * CR: disappearance of target and non-target lesions; no new lesions; pathological lymph nodes \< 10mm. * PR: 30% decrease in target lesions; non-target lesions not progressed or not evaluated; no new lesions. IORR was to be estimated for each mutation/regimen combination, with the associated 95% confidence intervals (using Clapper-Pearson method). Due to early accrual closure resulting in few subjects, only the number of subjects with CR or PR are provided, by mutation, with no statistical testing. |
| Secondary | Number of Participants by Highest Grade Adverse Event Reported | Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months. | Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. |
| Other | Agreement of Biopsy Mutation and Circulating Free Deoxyribonucleic Acid (cfDNA) Mutation Results | Baseline | For each mutation, the agreement of the biopsy result (present, absent, unavailable) and the cfDNA result (present, absent, unavailable) would be assessed. Agreement of cfDNA and biopsy results will be considered separately for MET amplification and for the gene mutations. This outcome measure was to be contingent upon FDA approval of the outcome measure analysis plan, which was not pursued due to the early accrual closure. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR), Per Investigator Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria | Baseline to 24 weeks | Eligible participants who started protocol treatment and had post-baseline disease assessment. Treatment arms with no evaluable participants are not shown. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival (PFS), Per Investigator Assessment Using RECIST v1.1 Criteria | Baseline to the date of the first disease progression / progressive disease, death, or last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months. | Eligible participants who started protocol treatment and had post-baseline disease assessment. Treatment arms with no evaluable participants are not shown. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Overall Response, Per Investigator Assessment Using RECIST v1.1 | Baseline to the date of the first disease progression / progressive disease, death, or last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months. | Eligible participants who started protocol treatment and had complete or partial response. Treatment arms with no evaluable participants are not shown. | months | MEAN |
| SECONDARY | Overall Survival (OS) | Baseline to the date of death or last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months. | Eligible participants who started protocol treatment, with post-baseline survival status. Treatment arms with no evaluable participants are not shown. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Intracranial Objective Response Rate, Per Investigator Assessment Using RECIST v1.1 | Baseline to 24 weeks | No participants with baseline CNS metastasis had evaluable post-baseline CNS metastasis assessment. | ||
| SECONDARY | Number of Participants by Highest Grade Adverse Event Reported | Baseline to the date of last known follow-up. Maximum follow-up time was 33.6 months, median 8.9 months. | Eligible participants who started protocol treatment, with adverse event data. Treatment arms with no evaluable participants are not shown. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Agreement of Biopsy Mutation and Circulating Free Deoxyribonucleic Acid (cfDNA) Mutation Results | Baseline | No assay data for analysis was received. |
Source ClinicalTrials.gov
Results by group51
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR), Per Investigator Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria | Lorlatinib | Mutation = I1171: BOR of CR or PR | 1 | Participants | |
| Objective Response Rate (ORR), Per Investigator Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria | LDK378 (Ceritinib) | Mutation = I1171: BOR of CR or PR | 0 | Participants | |
| Objective Response Rate (ORR), Per Investigator Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria | Brigatinib | Mutation = I1171: BOR of CR or PR | 0 | Participants | |
| Objective Response Rate (ORR), Per Investigator Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria | Lorlatinib | Mutation = None: BOR of CR or PR | 2 | Participants | |
| Objective Response Rate (ORR), Per Investigator Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria | Brigatinib | Mutation = None: BOR of CR or PR | 1 | Participants | |
| Objective Response Rate (ORR), Per Investigator Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria | Ensartinib | Mutation = None: BOR of CR or PR | 0 | Participants | |
| Progression-free Survival (PFS), Per Investigator Assessment Using RECIST v1.1 Criteria | Lorlatinib | Mutation = I1107: progression or death | 0 | Participants | |
| Progression-free Survival (PFS), Per Investigator Assessment Using RECIST v1.1 Criteria | LDK378 (Ceritinib) | Mutation = I1107: progression or death | 0 | Participants | |
| Progression-free Survival (PFS), Per Investigator Assessment Using RECIST v1.1 Criteria | Brigatinib | Mutation = I1107: progression or death | 1 | Participants | |
| Progression-free Survival (PFS), Per Investigator Assessment Using RECIST v1.1 Criteria | Lorlatinib | Mutation = none: progression or death | 1 | Participants |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lorlatinib | 3 | |
| Overall Study | STARTED | LDK378 (Ceritinib) | 1 | |
| Overall Study | STARTED | Alectinib | 0 | |
| Overall Study | STARTED | Brigatinib | 2 | |
| Overall Study | STARTED | Ensartinib | 3 | |
| Overall Study | STARTED | Crizotinib | 0 | |
| Overall Study | STARTED | Pemetrexed +/- Cisplatin or Carboplatin | 1 | |
| Overall Study | Disease Assessment Population | Lorlatinib | 3 | |
| Overall Study | Disease Assessment Population | LDK378 (Ceritinib) | 1 | |
| Overall Study | Disease Assessment Population | Alectinib | 0 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events540
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 | Anemia | Blood and lymphatic system disorders | Lorlatinib (Mutations) | 0 | 1 | |
| other | Anemia | Blood and lymphatic system disorders | Lorlatinib (no Mutations) | 1 | 2 | |
| other | Anemia | Blood and lymphatic system disorders | LDK378 (Ceritinib) | 0 | 1 | |
| other | Anemia | Blood and lymphatic system disorders | Brigatinib (Mutations) | 0 | 1 | |
| other | Anemia | Blood and lymphatic system disorders | Brigatinib (no Mutations) | 1 | 1 | |
| other | Anemia | Blood and lymphatic system disorders | Ensartinib | 1 | 3 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Lorlatinib (Mutations) | 1 | 1 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Lorlatinib (no Mutations) | 0 | 2 | |
| other | Eosinophilia | Blood and lymphatic system disorders | LDK378 (Ceritinib) | 0 | 1 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Brigatinib (Mutations) | 0 | 1 |
1 to 10 of 540Source ClinicalTrials.gov
See all 540 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lorlatinib (Mutations) | 0 | 1 |
| Total, all-cause mortality | Lorlatinib (no Mutations) | 0 | 2 |
| Total, all-cause mortality | LDK378 (Ceritinib) | 0 | 1 |
| Total, all-cause mortality | Brigatinib (Mutations) | 0 | 1 |
| Total, all-cause mortality | Brigatinib (no Mutations) | 1 | 1 |
| Total, all-cause mortality | Ensartinib | 2 | 3 |
| Total, other adverse events | Lorlatinib (Mutations) | 1 | 1 |
| Total, other adverse events | Lorlatinib (no Mutations) | 2 | 2 |
| Total, other adverse events | LDK378 (Ceritinib) | 1 | 1 |
| Total, other adverse events | Brigatinib (Mutations) | 1 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
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/NCT03737994
GET https://conductscience.org/api/trials/v1/NCT03737994/results?page=2