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

Conditions

• Metastatic Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — DRUG
  Durvalumab IV Cohort A: Every 4 weeks (q4w) Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1
• Danvatirsen — DRUG
  Danvatirsen IV Loading dose Cycle 1 Day 1, Cycle 1 Day 3, and Cycle 1 Day 5 then once a week (q1w) starting at Cycle 1 Day 8
• Oleclumab — DRUG
  Oleclumab IV Cohort A: Every 2 weeks (q2w) for first 2 cycles, then every 4 weeks (q4w) starting at Cycle 3 Day 1 Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1
• MEDI5752 — DRUG
  MEDI5752 IV Every 3 weeks (q3w)
• Pemetrexed — DRUG
  Pemetrexed IV Day 1 of each 21-day cycle Arm B1: Day 1 of each 21-day cycle for the first 4 cycles then either every 3 weeks (q3w) or every 4 weeks (q4w) (per investigator discretion) thereafter Arm B2 and B3: Day 1 of each 21-day cycle for the first 4 cycles then Day 1 of each 28-day cycle (q4w) thereafter Arm B5: Day 1 of each 21-day cycle throughout the study
• Carboplatin — DRUG
  Carboplatin IV Day 1 of each 21-day cycle
• Gemcitabine — DRUG
  Gemcitabine IV Days 1 and 8 of each 21-day cycle
• Cisplatin — DRUG
  Cisplatin IV Day 1 of each 21-day cycle
• Nab-paclitaxel — DRUG
  Nab-paclitaxel IV Days 1, 8, and 15 of each 21-day cycle
• AZD2936 — DRUG
  AZD2936 IV

Study Details

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)

Key Dates

Start date

Dec 27, 2018

Status verified

May 2026

Primary completion

May 23, 2023

Completion

Jul 1, 2026

Study Design

Enrollment

175 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: A1
  Durvalumab
• Experimental: A2
  Durvalumab + danvatirsen
• Experimental: A3
  Durvalumab + oleclumab
• Experimental: A4
  MEDI5752
• Experimental: B1
  Durvalumab + Investigator's choice of chemotherapy
• Experimental: B2
  Durvalumab + Investigator's choice of chemotherapy + danvatirsen
• Experimental: B3
  Durvalumab + investigator's choice of chemotherapy + oleclumab
• Experimental: B4
  MEDI5752
• Experimental: A5
  AZD2936
• Experimental: B5
  AZD2936 + chemotherapy

Primary Outcome Measure

Assessment of AEs by CTCAE v5.0 [ Time Frame: From informed consent until the safety follow-up visit 3 months after the last dose of study drug, or until the final data cut-off (DCO) date, whichever is earlier. ]

Locations (3)

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