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

NCT03944772 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2025-01-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Osimertinib

Osimertinib given orally at 80 mg once daily

DRUG

Savolitinib

Savolitinib will be given orally at 300 mg or 600mg once daily

DRUG

Gefitinib

Gefitinib given orally at 250 mg once daily

DRUG

Necitumumab

Necitumumab given IV at 800 mg on Day 1 and Day 8 of every 3-week cycle

DRUG

Durvalumab

Durvalumab given IV at 1500 mg on Day 1 of every cycle

DRUG

Carboplatin

Carboplatin given IV on Day 1 of every 21-day cycle for up to 6 cycles

DRUG

Pemetrexed

Pemetrexed given IV at 500 mg/m2 body BSA on Day 1 of every cycle

DRUG

Alectinib

Alectinib given orally at 600mg twice daily and for Japanese patients at 300mg twice daily.

DRUG

Selpercatinib

Selpercatinib given orally at 160mg twice daily

DRUG

Selumetinib

Selumetinib given orally at 75 mg twice daily for 4 days, followed by 3 days off treatment

DRUG

Etoposide

Etoposide 80-100 mg/m2 given IV on day 1, 2 and 3 of every 21-day cycle for up to 4 cycles.

DRUG

Cisplatin

Cisplatin 75-80 mg/m2 given IV on days 1 of each cycle

DRUG

Datopotamab deruxtecan

Datopotamab deruxtecan given IV at 4 or 6 mg/kg on Day 1 of every 3-week cycle.

Sponsors & Collaborators

Principal Investigators

  • Helena A Yu, MD · Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-25
Primary Completion
2025-05-06
Completion
2025-05-06
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Italy
  • Japan
  • Netherlands
  • Norway
  • South Korea
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT03944772 on ClinicalTrials.gov