Trial · NCT02134912
S1300: Pemetrexed Disodium With or Without Crizotinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer That Has Progressed After Crizotinib
NCT02134912, Phase 2, Terminated, SWOG Cancer Research Network; results first posted 2019-05-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. S1300: Pemetrexed Disodium With or Without Crizotinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer That Has Progressed After Crizotinib. Trials, record NCT02134912. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02134912
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- S1300: Pemetrexed Disodium With or Without Crizotinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer That Has Progressed After Crizotinib
- NCT number
- NCT02134912
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- SWOG Cancer Research Network
- Conditions
- Adenocarcinoma of the Lung, Large Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- Interventions
- crizotinib, pemetrexed disodium, laboratory biomarker analysis, pharmacological study
- First posted
- 2014-05-09
- Last updated
- 2020-02-20
- Results first posted
- 2019-05-01
- Limitations and caveats
- The one patient that enrolled immediately withdrew consent \[enrolled the day before the study closed\]. No manuscript will be forthcoming.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PFS Between Patients Randomized to Receive Pemetrexed Disodium Monotherapy Versus Crizotinib and Pemetrexed Disodium Combination Therapy | From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years | A stratified log-rank test at the 0.10 level will be used to test the primary hypothesis comparing the two treatment arms. |
| Secondary | Incidence of Adverse Events of Crizotinib in Combination With Pemetrexed Disodium, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Up to 3 years | Comparisons of toxicities rates will be done using a Fisher's exact or chi-squared test of independence, when appropriate using 10% as the significance threshold. Within each treatment arm, any toxicity with at least 5% prevalence has at least a 95% chance of being observed. |
| Secondary | Response Rate (Confirmed and Unconfirmed) With Pemetrexed Disodium Monotherapy | Up to 3 years | Comparisons of response rates will be done using a chi-square test of independence using 10% as the significance threshold. Within each treatment arm, response rates can be estimated to within 13% (with 95% confidence). |
| Secondary | Response Rates (Confirmed and Unconfirmed) of Crizotinib With Pemetrexed Disodium | Up to 3 years | Comparisons of response rates will be done using a chi-square test of independence using 10% as the significance threshold. Within each treatment arm, response rates can be estimated to within 13% (with 95% confidence). |
| Secondary | Patterns of Failure | Up to 3 years | Defined as CNS-only, extra-CNS, and both CNS and extra-CNS progression between the treatment arms. Evaluated within each treatment arm using cumulative incidence curves. |
| Secondary | Overall Survival | Up to 3 years | Differences in OS by treatment arm will be evaluated using a 1-sided log-rank test with significant level of 10%. |
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 | PFS Between Patients Randomized to Receive Pemetrexed Disodium Monotherapy Versus Crizotinib and Pemetrexed Disodium Combination Therapy | From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years | The one patient that enrolled immediately withdrew consent \[enrolled the day before the study closed\]. No manuscript will be forthcoming. | ||
| SECONDARY | Incidence of Adverse Events of Crizotinib in Combination With Pemetrexed Disodium, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Up to 3 years | The one patient that enrolled immediately withdrew consent \[enrolled the day before the study closed\]. No manuscript will be forthcoming. | ||
| SECONDARY | Response Rate (Confirmed and Unconfirmed) With Pemetrexed Disodium Monotherapy | Up to 3 years | The one patient that enrolled immediately withdrew consent \[enrolled the day before the study closed\]. No manuscript will be forthcoming. | ||
| SECONDARY | Response Rates (Confirmed and Unconfirmed) of Crizotinib With Pemetrexed Disodium | Up to 3 years | The one patient that enrolled immediately withdrew consent \[enrolled the day before the study closed\]. No manuscript will be forthcoming. | ||
| SECONDARY | Patterns of Failure | Up to 3 years | The one patient that enrolled immediately withdrew consent \[enrolled the day before the study closed\]. No manuscript will be forthcoming. | ||
| SECONDARY | Overall Survival | Up to 3 years | The one patient that enrolled immediately withdrew consent \[enrolled the day before the study closed\]. No manuscript will be forthcoming. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Crizotinib, Pemetrexed Disodium) | 0 | |
| Overall Study | STARTED | Arm II (Pemetrexed Disodium) | 0 | |
| Overall Study | COMPLETED | Arm I (Crizotinib, Pemetrexed Disodium) | 0 | |
| Overall Study | COMPLETED | Arm II (Pemetrexed Disodium) | 0 | |
| Overall Study | NOT COMPLETED | Arm I (Crizotinib, Pemetrexed Disodium) | 0 | |
| Overall Study | NOT COMPLETED | Arm II (Pemetrexed Disodium) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Crizotinib, Pemetrexed Disodium) | 0 | 0 |
| Total, all-cause mortality | Arm II (Pemetrexed Disodium) | 0 | 0 |
| Total, other adverse events | Arm I (Crizotinib, Pemetrexed Disodium) | 0 | 0 |
| Total, other adverse events | Arm II (Pemetrexed Disodium) | 0 | 0 |
| Total, serious adverse events | Arm I (Crizotinib, Pemetrexed Disodium) | 0 | 0 |
| Total, serious adverse events | Arm II (Pemetrexed Disodium) | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| U10CA180888 | SWOG Network Group Operations Center of the NCTN | LARA, PRIMO N.; HERSHMAN, DAWN | UNIVERSITY OF CALIFORNIA AT DAVIS | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA032102 | Southwest Oncology Group Treatment Grant | BLANKE, CHARLES D. | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2013 | 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/NCT02134912
GET https://conductscience.org/api/trials/v1/NCT02134912/registered