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Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer

NCT03794544 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2022-02-24

Study results available
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Summary

Study D9108C00002 (NeoCOAST) is a platform study assessing the effectiveness and safety of neoadjuvant durvalumab alone or in combination with novel agents in participants with resectable, early-stage (Stage I \[\>2cm\] to IIIA) non-small cell lung cancer (NSCLC).

Conditions

  • Resectable
  • Early-stage
  • NSCLC

Interventions

DRUG

Durvalumab

Durvalumab 1500 mg IV will be administered Q4W (on Week 1 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.

COMBINATION_PRODUCT

Oleclumab

Oleclumab 3000 mg IV will be administered Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.

COMBINATION_PRODUCT

Monalizumab

Monalizumab 750 mg IV will be administered Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.

COMBINATION_PRODUCT

Danvatirsen

Danvatirsen 200 mg IV will be administered on Days 1, 3, and 5 of Week 0 (7-day danvatirsen lead-in period) and later every week (on Week 1 Day 1, Week 2 Day 1, Week 3 Day 1, and Week 4 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-03-08
Primary Completion
2021-01-13
Completion
2021-01-13
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Italy
  • Portugal
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03794544 on ClinicalTrials.gov