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Tyrosine Kinase Inhibitor

Multiple Therapies for Non-Small Cell Lung Cancer (ORCHARD Trial)

Phase 2
Waitlist Available
Led By Helena A Yu, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
NSCLC with locally advanced or metastatic disease not amenable to curative surgery or radiotherapy at study entry
Evidence of radiological disease progression on first-line monotherapy with osimertinib 80 mg po QD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up continuously from first dose to end of safety follow up after study treatment discontinuation (approximately up to 21 months)
Awards & highlights

ORCHARD Trial Summary

This trial will test the effectiveness of different treatments for people with lung cancer who have stopped responding to a previous treatment. It will also look at the side effects of these treatments.

Who is the study for?
This trial is for adults with advanced non-small cell lung cancer that has worsened despite first-line treatment with Osimertinib. Participants must have a specific EGFR mutation, measurable disease progression, and be able to undergo a biopsy. They should only have had Osimertinib as their prior therapy and not have experienced severe side effects or rapid disease progression on it.Check my eligibility
What is being tested?
The study tests the effectiveness of various treatments like Pemetrexed, Datopotamab deruxtecan, Alectinib, among others in patients whose cancer progressed after initial Osimertinib therapy. It's designed to assess multiple treatments' safety and how well they work in different modules.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site, fatigue, nausea, blood count changes leading to increased infection risk or bleeding tendencies. Organ-specific inflammation may occur depending on which drug is used.

ORCHARD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung cancer cannot be cured with surgery or radiation.
Select...
My cancer has worsened despite taking osimertinib.
Select...
My lung cancer has EGFR mutations sensitive to specific treatments.
Select...
My tumor can be biopsied, and I am in stable health.

ORCHARD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~continuously from first dose to end of safety follow up after study treatment discontinuation (approximately up to 21 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and continuously from first dose to end of safety follow up after study treatment discontinuation (approximately up to 21 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Duration of response (DoR)
Incidence of Treatment-emergent adverse events (AEs) and serious adverse events (SAEs) as characterized and graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event [CTCAE] v5
Overall survival (OS)
+2 more

Side effects data

From 2020 Phase 4 trial • 60 Patients • NCT03853551
10%
Blood creatine phosphokinase increased
10%
Fatigue
8%
Decreased appetite
8%
Diarrhoea
8%
Cough
7%
Mucosal inflammation
7%
Rash
7%
Pain in extremity
7%
Constipation
7%
Thrombocytopenia
7%
Paronychia
3%
Dyspnoea
2%
Dengue fever
2%
Disease progression
2%
Cardio-respiratory arrest
2%
Cataract
2%
Mouth Ulceration
2%
Deep Vein Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

ORCHARD Trial Design

11Treatment groups
Experimental Treatment
Active Control
Group I: Module 9: Osimertinib + SelumetinibExperimental Treatment2 Interventions
The patients in this group will receive osimertinib taken in combination with selumetinib
Group II: Module 8: Osimertinib + Pemetrexed + Carboplatin or Cisplatin.Experimental Treatment4 Interventions
The patients in this group will receive Osimertinib plus platinum-containing doublet (pemetrexed + carboplatin or cisplatin).
Group III: Module 7: Etoposide + Durvalumab + Carboplatin or CisplatinExperimental Treatment4 Interventions
The patients in this group will receive platinum-containing doublet (etoposide + carboplatin or cisplatin) taken in combination with durvalumab.
Group IV: Module 6: Osimertinib + SelpercatinibExperimental Treatment2 Interventions
The patients in this group will receive osimertinib taken in combination with selpercatinib
Group V: Module 5: Osimertinib + AlectinibExperimental Treatment2 Interventions
The patients in this group will receive osimertinib taken in combination with alectinib
Group VI: Module 4: Carboplatin + Pemetrexed + Durvalumab)Experimental Treatment3 Interventions
The patients in this group will receive platinum-containing doublet (carboplatin + pemetrexed) taken in combination with durvalumab.
Group VII: Module 3: Osimertinib + NecitumumabExperimental Treatment2 Interventions
The patients in this group will receive osimertinib taken in combination with necitumumab
Group VIII: Module 2: Osimertinib + GefitinibExperimental Treatment2 Interventions
The patients in this group will receive osimertinib taken in combination with gefitinib
Group IX: Module 1: Osimertinib + SavolitinibExperimental Treatment2 Interventions
The patients in this group will receive osimertinib taken in combination with savolitinib
Group X: Module 10: Osimertinib + datopotamab deruxtecanExperimental Treatment2 Interventions
The patients in this group will receive osimertinib taken in combination with datopotamab deruxtecan.
Group XI: Observational Cohort: No study drugActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
2010
Completed Phase 3
~2440
Selumetinib
2010
Completed Phase 2
~2140
Pemetrexed
2014
Completed Phase 3
~5250
Durvalumab
2017
Completed Phase 2
~3870
Savolitinib
2019
Completed Phase 1
~110
Gefitinib
2005
Completed Phase 3
~2440
Necitumumab
2013
Completed Phase 3
~1390
Alectinib
2015
Completed Phase 3
~2400
Cisplatin
2013
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670
Selpercatinib
2021
Completed Phase 1
~600
Osimertinib
2017
Completed Phase 4
~1010

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,287 Previous Clinical Trials
288,619,902 Total Patients Enrolled
Helena A Yu, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA

Media Library

Osimertinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03944772 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Module 7: Etoposide + Durvalumab + Carboplatin or Cisplatin, Module 4: Carboplatin + Pemetrexed + Durvalumab), Observational Cohort: No study drug, Module 5: Osimertinib + Alectinib, Module 6: Osimertinib + Selpercatinib, Module 8: Osimertinib + Pemetrexed + Carboplatin or Cisplatin., Module 9: Osimertinib + Selumetinib, Module 10: Osimertinib + datopotamab deruxtecan, Module 1: Osimertinib + Savolitinib, Module 2: Osimertinib + Gefitinib, Module 3: Osimertinib + Necitumumab
Non-Small Cell Lung Cancer Clinical Trial 2023: Osimertinib Highlights & Side Effects. Trial Name: NCT03944772 — Phase 2
Osimertinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03944772 — Phase 2
~35 spots leftby May 2025
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