Limertinib Plus Carboplatin and Etoposide for EGFR-mutant NSCLC With SCLC Transformation After EGFR-TKI Progression

NCT07001995 | Not Yet Recruiting Phase 2

• 1 other identifier: CALLISTO
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, prospective study and aims to evaluate the efficacy and safety of limertinib combined with etoposide and carboplatin in EGFR-mutant NSCLC patients who develop small-cell lung cancer transformation following progression on EGFR-TKI therapy.

Conditions

Non Small Cell Lung Cancer NSCLC; Small Cell Lung Cancer; Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  define as first dose to first documented disease progression assessed by investigator or death due to any cause

  Time from first subject dose to study completion, or up to 36 month

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Time from first subject dose to study completion, or up to 36 month

• Disease control response (DcR)

  Time from first subject dose to study completion, or up to 36 month

• Duration of Response (DoR)

  Time from first subject dose to study completion, or up to 36 month

• Adverse events (AEs)

  From first dose to the last dose, up to 24 month

Study Arms (1)

Experimental group

EXPERIMENTAL

Limertinib Carboplatin Etoposide

Drug: limertinib; Drug: etoposide and carboplatin

Interventions

limertinib DRUG

limertinib 80 mg

Experimental group

etoposide and carboplatin DRUG

etoposide 100 mg/m² IV D1-3 + carboplatin AUC 5-6 IV

Also known as: EC

Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet all of the following to be eligible for enrollment:
• Signed written informed consent prior to any study-related procedures.
• Age ≥ 18 and ≤ 80 years.
• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with a sensitizing EGFR mutation (exon 19 deletion or L858R, with or without concurrent mutations).
• Prior treatment with EGFR-TKI, with documented disease progression and histologically confirmed small-cell lung cancer (SCLC) transformation.
• At least one measurable target lesion per RECIST v1.1.
• ECOG performance status 0-1 (see Appendix for ECOG scale).
• Estimated life expectancy \> 3 months.
• Adequate bone marrow function, defined as:
• ANC ≥ 1,500/mm³
• Hemoglobin ≥ 9 g/dL
• Platelets ≥ 90,000/mm³
• Adequate hepatic function, defined as:
• Total bilirubin ≤ 1.5 × ULN
• AST and ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with known hepatic metastases)

You may not qualify if:

• Patients meeting any of the following criteria will be excluded from the study:
• Histology at initial diagnosis of small-cell lung cancer (SCLC), large-cell carcinoma, or mixed tumor with predominant SCLC, large-cell, or neuroendocrine components.
• Prior treatment with a standard SCLC chemotherapy regimen (e.g., carboplatin/etoposide or cisplatin/etoposide) after SCLC transformation.
• Symptomatic or unstable brain metastases. Patients with a history of unstable brain metastases must have undergone definitive surgery or radiotherapy, remain clinically stable, and be off corticosteroids for cerebral edema for at least 14 days before enrollment.
• Any concurrent malignancy other than basal cell carcinoma of the skin or carcinoma in situ of the cervix. (Patients with a prior malignancy must be disease-free for ≥ 5 years to be eligible.)
• Pregnancy (confirmed by serum ß-hCG) or breastfeeding. Note: Women who have been postmenopausal for ≥ 12 months, or who have undergone hysterectomy, bilateral oophorectomy, or bilateral tubal ligation, are exempt from contraception requirements. Male participants must use effective contraception from the first dose of study drug until 180 days after the last dose.
• Active hepatitis B (HBV DNA \> 1,000 IU/mL) or hepatitis C infection (anti-HCV positive and/or HCV RNA \> 15 IU/L), or known HIV infection.
• Known hypersensitivity to lietinib, carboplatin, or etoposide.
• Psychiatric or cognitive disorders that would preclude informed consent or compliance with study requirements.
• Women planning pregnancy during the screening period or who, along with their partners, are not using effective contraception.
• Any other medical or psychosocial condition judged by the investigator to compromise patient safety or study integrity (e.g., poor compliance or comorbidities affecting efficacy assessment).

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Yongchang Zhang

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Carcinoma, Non-Small-Cell Lung

Interventions

Etoposide; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Coordination Complexes

Central Study Contacts

Yongchang zhang, MD

CONTACT

+8613873123436; zhangyongchang@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Medical Oncology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 3, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

CN (1)