NCT06918782Not yet recruitingPhase 2
Real-world Experience With Combination Chemotherapy and Osimertinib in Poor Prognostic Group of Metastatic EGFR-mutated Lung Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 9 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 47 (estimated)
- First submitted
- 25 Mar 2025
- Start date
- 1 May 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- The University of Hong Kong
- Diseases
- Lung cancer
- NCT number
- NCT06918782
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 47
- From 1 May 2025 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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.
Lab values
- 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);
Other
- Mixed NSCLC and small cell carcinoma;
- Major medical comorbidities with significant organ dysfunction;
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.