CTRI/2017/02/007857
Completed
Phase 4
An active surveillance to monitor the real world safety in Indian patients prescribed nintedanib for the treatment of locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy
Boehringer Ingelheim India Pvt Ltd0 sites28 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Boehringer Ingelheim India Pvt Ltd
- Enrollment
- 28
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients \=18 years of age with locally advanced and/or metastatic NSCLC of stage IIIB or IV, or recurrent NSCLC and adenocarcinoma histology after relapse or failure of first line of chemotherapy who are newly prescribed nintedanib according to the package insert.
- •2\. Willing to provide the informed consent
- •3\. Patients in whom further visit/contact is possible during the planned period of active surveillance
- •4\. Patients in whom information mentioned in the section 9\.2\.2\.2 of the protocol is available
Exclusion Criteria
- •1\. Patients who have taken nintedanib before participation in the study
- •2\. Patients who are positive for EGFR mutation
- •3\. Patients who are positive for ALK rearrangements
- •4\. Patients who are participating in a clinical trial
Outcomes
Primary Outcomes
Not specified
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