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

Part of paid clinical trials in La Jolla, California.

Sponsor
MedImmune LLC
Study ID
NCT03794544
Phase
PHASE2
Status
Completed

Conditions

  • Early-stage
  • NSCLC
  • Resectable

Eligibility Criteria

Sex
ALL
Age
18 Years - 102 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    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.
  • Oleclumab — COMBINATION_PRODUCT
    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.
  • Monalizumab — COMBINATION_PRODUCT
    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.
  • Danvatirsen — COMBINATION_PRODUCT
    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.

Study Details

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).

Key Dates

Start date
Mar 8, 2019
Status verified
Feb 2022
Primary completion
Jan 13, 2021
Completion
Jan 13, 2021

Study Design

Enrollment
84 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab 1500 mg
    Participants will receive durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W; on Week 1 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection will be planned between Day 29 and Day 42. After surgical resection, participants will be followed up to Day 105 (starting from Week 1 Day 1).
  • Experimental: Durvalumab 1500 mg + Oleclumab 3000 mg
    Participants will receive durvalumab 1500 mg IV Q4W (on Week 1 Day 1) and oleclumab 3000 mg IV every 2 weeks (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. Surgical resection will be planned between Day 29 and Day 42. After surgical resection, participants will be followed up to Day 105 (starting from Week 1 Day 1).
  • Experimental: Durvalumab 1500 mg + Monalizumab 750 mg
    Participants will receive durvalumab 1500 mg IV Q4W (on Week 1 Day 1) and monalizumab 750 mg IV 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. Surgical resection will be planned between Day 29 and Day 42. After surgical resection, participants will be followed up to Day 105 (starting from Week 1 Day 1).
  • Experimental: Durvalumab 1500 mg + Danvatirsen 200 mg
    Participants will receive danvatirsen 200 mg IV on Days 1, 3, and 5 of Week 0 (7-day danvatirsen lead-in period), followed by durvalumab 1500 mg IV Q4W (on Week 1 Day 1) and danvatirsen 200 mg IV 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. Surgical resection will be planned between Day 29 and Day 42. After surgical resection, participants will be followed up to Day 105 (starting from Week 1 Day 1).

Primary Outcome Measure

Major Pathological Response Rate [ Time Frame: Day 1 through Day 42 ]

Locations (10)

FacilityCityStateZIPSite coordinators
Research SiteLa JollaCalifornia92093-
Research SiteFort MyersFlorida33901-
Research SiteLeesburgFlorida34748-
Research SiteBaltimoreMaryland21231-
Research SiteBuffaloNew York14263-
Research SiteNew YorkNew York10016-
Research SiteChattanoogaTennessee37404-
Research SiteNashvilleTennessee37203-
Research SiteHoustonTexas77030-
Research SiteFairfaxVirginia22031-

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