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NCT06918782

PHASE2

Real-world Experience With Combination Chemotherapy and Osimertinib in Poor Prognostic Group of Metastatic EGFR-mutated Lung Adenocarcinoma

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

Summary

The aims of this study are to determine the potential clinical benefits (in terms of PFS, objective response and OS) of add-on systemic chemotherapy (pemetrexed+carboplatin/cisplatin) to first-line osimertinib treatment among the poor prognostic group of metastatic EGFR-mutant lung adenocarcinoma, i.e. failure of plasma ctDNA EGFR mutant clearance at week 3 after osimertinib treatment

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-05-01

Completion Date

2027-12-31

Last Updated

2025-04-09

Healthy Volunteers

Conditions

Lung Cancer (NSCLC)

Interventions

DRUG

Osimertinib plus platinum doublet chemotherapy

Based on the FLAURA2 study (which was not subdivided into ctDNA clearance subgroups), it is hypothesized that adding systemic chemotherapy to osimertinib will prolong PFS and OS and increase objective response rate even among the poor prognostic subgroup with failed ctDNA clearance after initial osimertinib monotherapy. By incorporating systemic chemotherapy (pemetrexed/carboplatin) to first-line osimertinib treatment among the poor prognostic group of metastatic EGFR-mutant lung adenocarcinoma with failure of plasma ctDNA EGFR mutant clearance despite initial osimertinib treatment.

Inclusion Criteria: 1. Adults above 18 years old, both male and female; 2. Pathologically confirmed lung adenocarcinoma with stage IIIB/C or IV disease (TNM staging version 8); 3. Confirmed EGFR common sensitizing mutations (exon 21 L858R or exon 19 del) by locally approved molecular testing methods (allele-specific PCR or NGS) based on tumour tissues or plasma ctDNA; 4. Clinically decided for first-line systemic treatment with osimertinib; 5. Detectable pre-treatment plasma EGFR mutations (by Cobas EGFR Mutation Test v2) and failed clearance 3 weeks (+/- 5 days) after osimertinib treatment; 6. At least one measurable target lesion by RECIST v1.1 criteria; 7. Performance state (ECOG) ≤ 1 and life expectancy ≥ 12 weeks; 8. Females in reproductive age with negative pregnancy test and highly effective means of contraception during and ≥ 4 months after intervention period; 9. Males should agree to have highly effective means of contraception during and ≥ 4 months after intervention period; and 10. Written informed consent obtained. Exclusion Criteria: 1. Mixed NSCLC and small cell carcinoma; 2. Prior systemic anticancer treatment (targeted therapy, chemotherapy or immunotherapy) for metastatic stage NSCLC; 3. Prior adjuvant chemotherapy or targeted therapy within 6 months; 4. Local radiotherapy within 2 weeks or major surgery within 4 weeks; 5. Inadequate haematological function (haemoglobin \< 9 g/dL, neutrophils \< 1.5 x 109/L, platelets \< 100 x 109/L), renal function (serum creatinine ≥ 1.5 x upper limit of normal (ULN) or creatinine clearance \< 45 ml/min) or liver function (total bilirubin \> 1.5 x ULN, ALT/AST/ALP \> 3 x ULN; ALT/AST/ALP \> 5 x ULN for liver metastases; ALP \> 5 x ULN for bone metastases); 6. Major medical comorbidities with significant organ dysfunction; 7. Known active hepatitis B or C infection. Chronic hepatitis B on antiviral allowed as per institutional guideline for chemotherapy; 8. Malignancies other than NSCLC; and 9. Known hypersensitivity to pemetrexed or carboplatin.