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

NCT03819465 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2026-05-12

No results posted yet for this study

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)

Conditions

  • Metastatic Non-Small Cell Lung Cancer (NSCLC)

Interventions

DRUG

Durvalumab

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

DRUG

Danvatirsen

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

DRUG

Oleclumab

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

DRUG

MEDI5752

MEDI5752 IV Every 3 weeks (q3w)

DRUG

Pemetrexed

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

DRUG

Carboplatin

Carboplatin IV Day 1 of each 21-day cycle

DRUG

Gemcitabine

Gemcitabine IV Days 1 and 8 of each 21-day cycle

DRUG

Cisplatin

Cisplatin IV Day 1 of each 21-day cycle

DRUG

Nab-paclitaxel

Nab-paclitaxel IV Days 1, 8, and 15 of each 21-day cycle

DRUG

AZD2936

AZD2936 IV

Sponsors & Collaborators

Principal Investigators

  • Sandip Patel, MD · UCSD Morres Cancer Center

  • Chih-Hsin Yang, MD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-27
Primary Completion
2023-05-23
Completion
2026-07-01
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Poland
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03819465 on ClinicalTrials.gov