A study of nivolumab and ipilimumab in untreated patients with stage 3 NSCLC that is unable or not planned to be removed by surgery

Phase 1

• Conditions: Previously Untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC); MedDRA version: 21.1Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-001222-98-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

- Eastern Cooperative Oncology Group (ECOG) performance status =1
- Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) histologically-confirmed NSCLC, according to 8th TNM classification
- Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease

Other protocol defined inclusion criteria could apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 770
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 630

Exclusion Criteria

- Any condition including medical, emotional, psychiatric, or logistical
that, in the opinion of the Investigator would preclude the patient from
adhering to the protocol or would increase the risk associated with study
participation
- Active infection requiring systemic therapy within 14 days prior to
randomization
- History of organ or tissue transplant that requires systemic use of
immune suppressive agents.
- Prior thoracic radiotherapy
Other protocol defined exclusion criteria could apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified