A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC

• Status: Active, not recruiting
• Trial end date: 2024-01-23
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to determine the efficacy and safety of durvalumab and/or novel oncology therapies, with or without chemotherapy, for first-line Stage IV Non-Small Cell Lung Cancer (NSCLC)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Carboplatin; Cisplatin; Durvalumab; Gemcitabine; Paclitaxel; Pemetrexed

Criteria

Inclusion Criteria:

• Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation

• No prior chemotherapy or any other systemic therapy for metastatic NSCLC

• Prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for advanced disease are eligible, if progression has occurred >12 months from end of last therapy

• Known tumor PD-L1 status

• WHO/ECOG status at 0 or 1 at enrollment

• Life expectancy of at least 12 weeks

• Troponin I or T ≤ ULN (per institutional guidelines)

Exclusion Criteria:

• Active or prior documented autoimmune or inflammatory disorders

• History of active primary immunodeficiency

• Any prior chemotherapy or any other systemic therapy for metastatic NSCLC

• Untreated CNS metastases