Trial · NCT02183870
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR); evaluation criteria: investigator assessed RECIST v.1.1 analysis | From time of beginning of treatment until the documention of response according to RECIST v1.1 (expected average 12 months) . | CT/MRI scans will be performed to evaluate the efficacy of crizotinib treatment in advanced adenocarcinoma of the lung harbouring ROS1 fusion genes (primary outcome measure: objective response rate (ORR) according to RECIST v.1.1) |
| Secondary | Progression Free Survival (PFS) according to RECIST v1.1; evaluation criteria: investigator assessed RECIST v.1.1 analysis | From time of beginning of treatment until the first documented event of progression according to RECIST v1.1 (expected average 12 months). | CT/MRI scans will be performed to assess the PFS during treatment period. |
| Secondary | Overall Survival (OS); evaluation criteria: investigator assessed RECIST v.1.1 analysis | From beginning to end of study (Last subject last visit (LSLV)) (up to approximately 24 months). | OS will be assessed by telephone calls every 3 months after the safety follow-up visit. |
| Secondary | Duration of Response (DR); evaluation criteria: investigator assessed RECIST v.1.1 analysis | From time of beginning of treatment until the documention of progression according to RECIST v1.1 (expected average 12 months). | CT/MRI scans will be performed to asses the DR. |
| Secondary | Time to Tumor Response; evaluation criteria: investigator assessed RECIST v.1.1 analysis | From time of beginning of treatment until the first documented event of response according to RECIST v1.1 (expected average 3 months). | CT/MRI scans will be performed to assess the Time to Tumor Response. |
| Secondary | Disease Control Rate (DCR); evaluation criteria: investigator assessed RECIST v.1.1 analysis | From beginning of treatment to week 6, 12 and 24 according to RECIST v1.1 (expected average 3 months). | CT/MRI scans will be performed at weeks 6, 12, 24 to assess the DCR. |
| Secondary | Safety/Adverse Events and tolerability in all patients treated with crizotinib assessed by number and severity of adverse events as recorded on the case report form, vital signs, laboratory variables, physical examination, electrocardiogram and RECIST1.1 | From beginning of treatment until 28 days post treatment (expected average 12 months). | Safety and tolerability will be assessed on every study visit and for 28 days after end of treatment. |
| Secondary | Patient Reported Outcomes (PRO) (EORTC QLQ-C30, EORTC QLQ-LC13) | Questionnaires (EORTC QLQ-LC13, EORTC QLQ-C30) completed at baseline and every 4 weeks from beginning of treatment until end of study. | Patient reported outcomes (PRO) of health-related quality of life (HRQoL), disease/treatment related symptoms of lung cancer and general health status |
| Secondary | To evaluate the efficacy of crizotinib treatment in the patient subgroup with ROS1 translocation confirmed by the CAGE technology regarding the objective response rate (ORR) (evaluation criteria: investigator assessed RECIST v1.1) | From time of beginning of treatment until the documention of response according to RECIST v1.1 (expected average 12 months) . | CT/MRI scans will be performed to evaluate the efficacy of crizotinib treatment in advanced adenocarcinoma of the lung harbouring ROS1 fusion genes as confirmed by CAGE sequencing |
| Secondary | Objective Response Rate (ORR), Overall Survival (OS), Progression Free Survival (PFS), Duration of Response (DR), Time to Tumor Response, Disease Control Rate (DCR); evaluation criteria: RECIST v1.1 by independent radiologic review | From time of beginning of treatment until the documention of response according to RECIST v1.1 (expected average 12 months) . | CT/MRI scans will be performed to evaluate the efficacy of crizotinib treatment |
| Other | Characterization of ROS1 fusion gene on a genomic level by CAGE Technology to identify the exact break-apart point as well as the involved fusion genes. | From beginning of screening of first patient to screening of last patient (expected average 24 months). | CAGE technology (Cap Analysis of Gene Expression) is an RNA based sequencing technology to identify the exact break-apart point as well as the fusion genes. |
| Other | Characterization of molecular and genetic mechanisms of resistance to crizotinib treatment in patients showing disease progression. | At time of disease progression (expected average 12 months). | Mechanisms of resistance to crizotinib will be analysed by molecular pathologic analyses, e.g. NGS and FISH. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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GET https://conductscience.org/api/trials/v1/NCT02183870/registered