Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)

Part of paid clinical trials in Duarte, California.

Sponsor
AstraZeneca
Study ID
NCT03944772
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    Osimertinib given orally at 80 mg once daily
  • Savolitinib — DRUG
    Savolitinib will be given orally at 300 mg or 600mg once daily
  • Gefitinib — DRUG
    Gefitinib given orally at 250 mg once daily
  • Necitumumab — DRUG
    Necitumumab given IV at 800 mg on Day 1 and Day 8 of every 3-week cycle
  • Durvalumab — DRUG
    Durvalumab given IV at 1500 mg on Day 1 of every cycle
  • Carboplatin — DRUG
    Carboplatin given IV on Day 1 of every 21-day cycle for up to 6 cycles
  • Pemetrexed — DRUG
    Pemetrexed given IV at 500 mg/m2 body BSA on Day 1 of every cycle
  • Alectinib — DRUG
    Alectinib given orally at 600mg twice daily and for Japanese patients at 300mg twice daily.
  • Selpercatinib — DRUG
    Selpercatinib given orally at 160mg twice daily
  • Selumetinib — DRUG
    Selumetinib given orally at 75 mg twice daily for 4 days, followed by 3 days off treatment
  • Etoposide — DRUG
    Etoposide 80-100 mg/m2 given IV on day 1, 2 and 3 of every 21-day cycle for up to 4 cycles.
  • Cisplatin — DRUG
    Cisplatin 75-80 mg/m2 given IV on days 1 of each cycle
  • Datopotamab deruxtecan — DRUG
    Datopotamab deruxtecan given IV at 4 or 6 mg/kg on Day 1 of every 3-week cycle.

Study Details

Phase 2 Platform Study in Patients with Advanced Non-Small Lung Cancer who progressed on First-Line Osimertinib Therapy. This study is modular in design, allowing evaluation of the efficacy, safety and tolerability of multiple study treatments.

Key Dates

Start date
Jun 25, 2019
Status verified
Dec 2024
Primary completion
May 6, 2025
Completion
May 6, 2025

Study Design

Enrollment
247 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1: Osimertinib + Savolitinib
    The patients in this group will receive osimertinib taken in combination with savolitinib
  • Experimental: Module 2: Osimertinib + Gefitinib
    The patients in this group will receive osimertinib taken in combination with gefitinib
  • Experimental: Module 3: Osimertinib + Necitumumab
    The patients in this group will receive osimertinib taken in combination with necitumumab
  • Experimental: Module 4: Carboplatin + Pemetrexed + Durvalumab)
    The patients in this group will receive platinum-containing doublet (carboplatin + pemetrexed) taken in combination with durvalumab.
  • No Intervention: Observational Cohort: No study drug
    Patients in this group will not receive study treatment but receive further anticancer care (Standard of Care therapy or other experimental therapies) or supportive care, as clinically indicated, in accordance with local practice. With Group C, the aim is to understand the clinical course and/or outcome for the overall clinical population after progression on first-line monotherapy with osimertinib.
  • Experimental: Module 5: Osimertinib + Alectinib
    The patients in this group will receive osimertinib taken in combination with alectinib
  • Experimental: Module 6: Osimertinib + Selpercatinib
    The patients in this group will receive osimertinib taken in combination with selpercatinib
  • Experimental: Module 7: Etoposide + Durvalumab + Carboplatin or Cisplatin
    The patients in this group will receive platinum-containing doublet (etoposide + carboplatin or cisplatin) taken in combination with durvalumab.
  • Experimental: Module 8: Osimertinib + Pemetrexed + Carboplatin or Cisplatin.
    The patients in this group will receive Osimertinib plus platinum-containing doublet (pemetrexed + carboplatin or cisplatin).
  • Experimental: Module 9: Osimertinib + Selumetinib
    The patients in this group will receive osimertinib taken in combination with selumetinib
  • Experimental: Module 10: Osimertinib + datopotamab deruxtecan
    The patients in this group will receive osimertinib taken in combination with datopotamab deruxtecan.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Measured from first dose until confirmed response or progression. For each patient this is expected to be 3 months on average ]

Locations (16)

FacilityCityStateZIP
Research SiteDuarteCalifornia91010
Research SiteLos AngelesCalifornia90048
Research SiteSacramentoCalifornia95817
Research SiteSanta MonicaCalifornia90404
Research SiteNew HavenConnecticut06510
Research SiteChicagoIllinois60612
Research SiteBaltimoreMaryland21224
Research SiteBostonMassachusetts02114
Research SiteBostonMassachusetts02215
Research SiteGrand RapidsMichigan49503
Research SiteNew YorkNew York10017
Research SiteNew YorkNew York10032
Research SitePortlandOregon97239
Research SitePittsburghPennsylvania15232
Research SiteHoustonTexas77030
Research SiteSeattleWashington98109

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