Status:
NOT_YET_RECRUITING
Real-world Experience With Combination Chemotherapy and Osimertinib in Poor Prognostic Group of Metastatic EGFR-mutated Lung Adenocarcinoma
Lead Sponsor:
The University of Hong Kong
Conditions:
Lung Cancer (NSCLC)
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 os...
Detailed Description
This is a single-arm clinical trial, subjects will be consented prior to the initiation of osimertinib (as per standard-of-care) with baseline plasma ctDNA EGFR mutations tested in QMH. Those with det...
Eligibility Criteria
Inclusion
- Adults above 18 years old, both male and female;
- Pathologically confirmed lung adenocarcinoma with stage IIIB/C or IV disease (TNM staging version 8);
- 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;
- Clinically decided for first-line systemic treatment with osimertinib;
- Detectable pre-treatment plasma EGFR mutations (by Cobas EGFR Mutation Test v2) and failed clearance 3 weeks (+/- 5 days) after osimertinib treatment;
- At least one measurable target lesion by RECIST v1.1 criteria;
- Performance state (ECOG) ≤ 1 and life expectancy ≥ 12 weeks;
- Females in reproductive age with negative pregnancy test and highly effective means of contraception during and ≥ 4 months after intervention period;
- Males should agree to have highly effective means of contraception during and ≥ 4 months after intervention period; and
- Written informed consent obtained.
Exclusion
- Mixed NSCLC and small cell carcinoma;
- Prior systemic anticancer treatment (targeted therapy, chemotherapy or immunotherapy) for metastatic stage NSCLC;
- Prior adjuvant chemotherapy or targeted therapy within 6 months;
- Local radiotherapy within 2 weeks or major surgery within 4 weeks;
- 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);
- Major medical comorbidities with significant organ dysfunction;
- Known active hepatitis B or C infection. Chronic hepatitis B on antiviral allowed as per institutional guideline for chemotherapy;
- Malignancies other than NSCLC; and
- Known hypersensitivity to pemetrexed or carboplatin.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT06918782
Start Date
May 1 2025
End Date
December 31 2027
Last Update
April 9 2025
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