New combo targets lung cancer that morphs after treatment
NCT ID NCT07001995
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of the targeted drug limertinib plus chemotherapy (etoposide and carboplatin) in 30 people with a specific type of lung cancer. These patients have a mutation in the EGFR gene and their cancer has changed from non-small cell to small cell lung cancer after standard treatment stopped working. The goal is to see if this new combo can slow down the cancer or shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- limertinib combined with etoposide and carboplatin
- What this could lead to
- If successful, this could offer a new treatment option for patients whose lung cancer has changed form and stopped responding to standard targeted therapy.
- What could go wrong
- This is a small, early-phase study with only 30 participants, so results may not apply to everyone. The combination may cause significant side effects and may not improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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) * Adequate renal function, defined as: * Serum creatinine within normal limits OR creatinine clearance ≥ 50 mL/min (Cockcroft-Gault) * For patients with BMI \< 18.5 or \> 30, eGFR ≥ 50 mL/min (MDRD) is acceptable * Adequate cardiac function, defined as LVEF ≥ 50% by MUGA scan or echocardiography. * Women of childbearing potential and men with partners of childbearing potential must agree to use effective contraception. Exclusion Criteria: * 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Yongchang Zhang
Changsha, Hunan, 410013, China
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