Status:
UNKNOWN
Osimertinib Plus Chemotherapy vs Osimertinib in EGFRm NSCLC With Persistence Week-3 ctDNA EGFRm After 1L Osimertinib
Lead Sponsor:
Beijing Cancer Prevention & Treatment Society
Collaborating Sponsors:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a prospective, randomised, open-label, positive-controlled study to investigate the efficacy and safety of Osimertinib plus Carboplatin/Pemetrexed versus Osimertinib monotherapy in metastatic ...
Eligibility Criteria
Inclusion
- Provision and signed of informed consent prior to any study specific procedures;
- Male or female, aged at least 18 years;
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1;
- Newly diagnosed, and histologically documented metastatic non-squamous NSCLC with sensitizing EGFR mutations positive, and classified as stage IV or recurrent NSCLC which are not amenable to curative surgery or radiotherapy;
- Life expectancy of at least 3 months at recruitment;
- Only the patients receiving osimertinib as 1L treatment and meeting the following criteria will be considered:
- A. Prior to 1L osimertinib:
- History of EGFRm (exon 19 deletion or exon 21 L858R) in the plasma ctDNA by the local testing methods.
- No previous systemic treatment. Adjuvant therapies, or definitive radiation/chemoradiation are permitted as long as treatment was completed at least 6 months prior to receiving 1L treatment.
- Patients with asymptomatic and stable CNS metastases for at least 2 weeks will be allowed, including leptomeningeal metastases.
- B. Prior to randomization: Patients after 3 weeks of 1L osimertinib treatment who have persistence ctDNA EGFRm by SuperARMS at 3 weeks will be considered to be enrolled. They will need to further meet the criteria below before randomization:
- Patients without disease progression by RECIST 1.1 evaluation;
- At least 1 measurable extracranial lesion according to RECIST 1.1 .
- Female subjects should be using highly effective contraceptive measures, and must have a negative pregnancy test and not be breast-feeding prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential.
- Male subjects should be willing to agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm.
Exclusion
- Involvement in the planning and/or conduct of the study;
- History of hypersensitivity to active or inactive excipients of Osimertinib and/or Pemetrexed and/or Carboplatin or drugs with a similar chemical structure or class to Osimertinib and/or Pemetrexed and/or Carboplatin;
- For patients, inability to collect plasma samples at baseline and disease progression;
- QT prolongation or any clinically important abnormalities in rhythm;
- Any evidence of severe or uncontrolled systemic diseases;
- Currently receiving medications or herbal supplements known to be strong inducers of CYP3A4;
- Any unresolved toxicities from prior therapy greater than CTCAE 5.0 grade 1 at the time of starting study treatment.
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib.
- Inadequate bone marrow reserve or organ function;
- Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
- Contraindication for osimertinib, pemetrexed and carboplatin according to China approved label.
- Women who are pregnant or breast-feeding.
Key Trial Info
Start Date :
December 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04769388
Start Date
December 28 2021
End Date
September 1 2024
Last Update
March 17 2022
Active Locations (1)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China