Post Marketing Surveillance of Nintedanib in Indian Patients With Non-small Cell Lung Cancer (NSCLC) After First-line Therapy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-28

Study Completion Date

2022-09-24

Brief Summary

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This active surveillance aims to collect the safety data of 100 NSCLC patients treated with nintedanib per the approved Indian label within 2 years from the date of commercial availability of the drug in India (23rd January 2017). The objective is to look at the safety of nintedanib in the real world setting.

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Group A

Patients who started treatment with nintedanib \& docetaxel after 23rd January, 2017 and have discontinued the drug at the time of participation in the active surveillance.

No interventions assigned to this group

Group B

Patients who started treatment with nintedanib \& docetaxel after 23rd January, 2017 and are continuing the drug at the time of participation in the active surveillance .

No interventions assigned to this group

Group C

Patients who have been newly prescribed nintedanib \& docetaxel at the time of participation in the active surveillance.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients ≥18 years of age with locally advanced and/or metastatic NSCLC of stage IIIB or IV, or recurrent NSCLC and adenocarcinoma histology after first line chemotherapy who have initiated or will initiate nintedanib \& docetaxel according to the package insert after the commercial availability of drug in India (23rd January 2017).
* Patients in whom it is possible to obtain voluntary informed consent from either the patient or patient's legally authorised representative (applicable for Group B and C patients).
* Patients in whom data collection is possible from the medical records (applicable for Group A and B patients).

Exclusion Criteria

* Patients who were previously treated with nintedanib.
* Patients who are positive for endothelial growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements
* Patients who are participating in a clinical trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No