Understanding Non-small Cell Lung Cancer Patient Characteristics, Treatment Patterns and Outcomes

NCT07215026 | Completed

• 1 other identifier: D9260R00023
• Study Type: observational
• Target: 833
• Locations: 1 country
• Sites: 1

Brief Summary

This is a retrospective, cross-sectional, non-interventional, multi-country survey-based chart audit study to evaluate real-world treatment patterns, patient clinical profiles, and clinical outcomes among a NSCLC patients receiving at least 1L SACT (Systemic anticancer therapy)

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Outcomes of interest are real-world overall survival (rwOS)

  Definition of rwOS rwOS is defined as the interval between the index date and the date of death due to any cause. \*Patients who are alive or for whom vital status is unknown at the time of data collection will be censored at the date the patient is last known to be alive.

  12 month

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population for the UNCOVER observational study consists of two main groups: participating physicians and their eligible patients. The protocol lays out robust criteria for both, ensuring relevant, high-quality clinical data across diverse regions.

You may qualify if:

• Biomarker Status:
• Either: EGFR mutation present Or: No actionable gene alterations (AGAs) detected (including EGFR, ALK, ROS1, NTRK, BRAF V600E, RET, MET, KRAS, HER2; patients not tested for these also eligible).
• Treatment Start Window: Initiated 1L SACT (systemic anticancer therapy) for advanced NSCLC between the date of first Tagrisso® (osimertinib) approval for NSCLC in their country and 31 December 2024.
• Age: 18 years or older at time of 1L SACT initiation.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

New Delhi, India

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: October 10, 2025
• Study Start: October 27, 2025
• Primary Completion: January 21, 2026
• Study Completion: January 21, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information

Locations

IN (1)