Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000025

EU PAS number

EUPAS1000000025

Study ID

1000000025

Official title and acronym

Non-Interventional Study - Use of lorlatinib in treatment-naïve adult patients with metastatic or locally advanced anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC) from India. (B7461047)

DARWIN EU® study

No

Study countries

India

Study description

This is an ambispective, multi-center, observational study investigating the safety and effectiveness of lorlatinib in advanced ALK-positive NSCLC patients in India according to the local labelling information.

This study will be conducted by design of retro-prospective approach. Therefore, there is no visit or activity mandated for the patients by this study. The investigator will collect patient’s data and record the information on each patient’s Case Report Form (CRF).

All patients diagnosed with advanced ALK-positive NSCLC with or without brain metastases, treatment naïve for metastatic disease, and prescribed lorlatinib according to routine clinical practice at up-to 10 centers in India and willing to participate will be followed for 18 months after taking informed consent from them.

All assessments described in this protocol are performed as part of normal clinical practice or standard practice guidelines for the patient population and healthcare provider specialty in India where this noninterventional study is being conducted.

Study status

Ongoing
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution
Indegene Limited

Contact details

Nishtha Sehra

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable