← Back to Search

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ continuously from first dose to end of safety follow up after study treatment discontinuation (approximately up to 21 months)

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

Decreased appetite

Diarrhoea

Cough

Mucosal inflammation

Rash

Pain in extremity

Constipation

Thrombocytopenia

Paronychia

Dyspnoea

Dengue fever

Disease progression

Cardio-respiratory arrest

Cataract

Mouth Ulceration

Deep Vein Thrombosis

100%

80%

60%

40%

20%

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

~2050

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,257 Previous Clinical Trials

288,593,538 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for individuals to enroll in this clinical experiment?

"Affirmative, according to the clinicaltrials.gov portal this trial is presently in need of participants. This medical research was initially posted on June 25th 2019 and its most recent update occurred November 22nd 2022. The study seeks 250 patients across 18 different sites."

Answered by AI

Is it feasible for me to join this medical experiment?

"This medical study is searching for individuals between 18 and 130 who are diagnosed with lung cancer. A total of 250 participants need to be recruited in order to gain admittance."

Answered by AI

Is Osimertinib a reliable medication with minimal adverse effects?

"Safety estimates of Osimertinib were assigned a score of 2 due to its Phase 2 clinical trial status, where there has been some testing in regards to safety but not efficacy."

Answered by AI

How many facilities offer this clinical investigation?

"At the present moment, a total of 18 clinical trial sites are accepting participants. These locations span from Boston to Toronto and Houston as well as other nearby cities; thus, it is recommended that individuals select the closest site so they can limit their travel needs if partaking in this experiment."

Answered by AI

Are there any extant research efforts into the use of Osimertinib?

"Osimertinib was first investigated at City of Hope Comprehensive Cancer Center in 1997. Since then, 2366 studies have been completed and 1723 are presently recruiting participants. The majority of the extant trials can be found around Boston, MA."

Answered by AI

How is Osimertinib usually utilized to treat patients?

"Osimertinib is an efficacious treatment option for prostate cancer, small cell lung cancer (SCLC), and at the outset of therapy."

Answered by AI

How many individuals have signed up to participate in the experiment?

"Affirmative, the clinical trial is currently enrolling applicants. According to records on clinicaltrials.gov, it was posted on June 25th 2019 and last updated November 22nd 2022 with a goal of recruiting 250 participants among 18 sites."

Answered by AI

Is the age restriction for participants of this study under 35 years old?

"This clinical trial is looking for individuals aged 18 to 130. Meanwhile, there are separate trials tailored to those younger than 18 and older than 65; 248 and 3601 respectively."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Targeting MET in EGFR Resistance in Non-small-cell Lung Cancer—ready for Daily Practice?

Schmid, Sabine, Martin Früh, and Solange Peters. 2020. “Targeting MET in EGFR Resistance in Non-small-cell Lung Cancer—ready for Daily Practice?”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(19)30859-9.

Clinical Lung CancerJournal

Biomarker-directed Phase II Platform Study in Patients with EGFR Sensitizing Mutation-positive Advanced/metastatic Non-small Cell Lung Cancer Whose Disease Has Progressed on First-line Osimertinib Therapy (ORCHARD)

Yu, Helena A., Sarah B. Goldberg, Xiuning Le, Zofia Piotrowska, Jonathan W. Goldman, Adrianus J. De Langen, Isamu Okamoto, et al.. 2021. “Biomarker-directed Phase II Platform Study in Patients with EGFR Sensitizing Mutation-positive Advanced/metastatic Non-small Cell Lung Cancer Whose Disease Has Progressed on First-line Osimertinib Therapy (ORCHARD)”. Clinical Lung Cancer. Elsevier BV. doi:10.1016/j.cllc.2021.06.006.

clinicaltrials.govStudy

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

2019. "Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03944772.

All > Lung Cancer Boston