Small Cell Lung CancerPhase 2NCT07001995
Limertinib Plus Carboplatin and Etoposide for EGFR-mutant NSCLC With SCLC Transformation After EGFR-TKI Progression
A Phase 2 study testing limertinib and etoposide and carboplatin in people with Small Cell Lung Cancer and Non Small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Small Cell Lung Cancer, Non Small Cell Lung Cancer, Non Small Cell Lung Cancer NSCLC
- What is being tested?
- limertinib and etoposide and carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 30 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Yongchang Zhang
Changsha, Hunan, 410013
Yongchang Zhang, MD, +8613873123436 ext. +8613873123436, zhangyongchang@csu.edu.cn
About this study
Official title: A Single-center, Single-arm Phase II Study of Limertinib Plus Carboplatin and Etoposide in EGFR-mutant NSCLC Patients With SCLC Transformation After EGFR-TKI Progression
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.
Read the detailed description
This is a single-center, prospective interventional Phase II study designed to assess the efficacy, safety and mechanism of resistance to limertinib combined with carboplatin and etoposide in EGFR-mutant NSCLC patients who have histologically confirmed small-cell transformation after progression on EGFR-TKI therapy. Thirty patients will receive Limertinib orally once daily (80 mg) plus carboplatin (AUC 5-6, day 1) and etoposide (100 mg/m², days 1-3) every 21 days until disease progression or unacceptable toxicity. Radiographic tumor evaluation will be conducted every 6 weeks per RECIST v1.1. Tumor tissue and blood specimens will be collected at baseline and upon disease progression for next-generation sequencing to elucidate the molecular mechanisms underlying histological transformation.
- Being tested
- limertinib, etoposide and carboplatin
- Medical subject headings
- Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
limertinibDrug
limertinib 80 mg
etoposide and carboplatinDrug
Also called EC
etoposide 100 mg/m² IV D1-3 + carboplatin AUC 5-6 IV
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Limertinib Carboplatin Etoposide Receives: Drug: limertinib; Drug: etoposide and carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
define as first dose to first documented disease progression assessed by investigator or death due to any cause
Measured: Time from first subject dose to study completion, or up to 36 month
Secondary outcomes (4)
Objective Response Rate (ORR)
According to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)
Measured: Time from first subject dose to study completion, or up to 36 month
Disease control response (DcR)
According to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) , partial response (PR) or stable disease (SD)
Measured: Time from first subject dose to study completion, or up to 36 month
Duration of Response (DoR)
To assess duration of response for subjects with CR or PR according to RECIST version 1.1 by investigator , defined as the time from the first documented CR or PR to disease progression or death
Measured: Time from first subject dose to study completion, or up to 36 month
Adverse events (AEs)
Number of participants with adverse events (AEs) according to CTCAE 5.0
Measured: From first dose to the last dose, up to 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 May 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongchang Zhang, Hunan Province Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001995
- Sponsor's protocol ID
- CALLISTO
- Status last verified
- Mar 2026
- First submitted
- 25 May 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-arm Phase II Study of Limertinib Plus Carboplatin and Etoposide in EGFR-mutant NSCLC Patients With SCLC Transformation After EGFR-TKI Progression
- ClinicalTrials.gov ID
- NCT07001995
- Acronym / sponsor ID
- CALLISTO
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-center, prospective interventional Phase II study designed to assess the efficacy, safety and mechanism of resistance to limertinib combined with carboplatin and etoposide in EGFR-mutant NSCLC patients who have histologically confirmed small-cell transformation after progression on EGFR-TKI therapy. Thirty patients will receive Limertinib orally once daily (80 mg) plus carboplatin (AUC 5-6, day 1) and etoposide (100 mg/m², days 1-3) every 21 days until disease progression or unacceptable toxicity. Radiographic tumor evaluation will be conducted every 6 weeks per RECIST v1.1. Tumor tissue and blood specimens will be collected at baseline and upon disease progression for next-generation sequencing to elucidate the molecular mechanisms underlying histological transformation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: limertinib, Drug: etoposide and carboplatinLimertinib Carboplatin Etoposide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| limertiniblimertinib 80 mg | Drug | Experimental group |
| etoposide and carboplatinAlso: ECetoposide 100 mg/m² IV D1-3 + carboplatin AUC 5-6 IV | Drug | Experimental group |
Primary outcome
Progression-free survival (PFS)
Time frame: Time from first subject dose to study completion, or up to 36 month
define as first dose to first documented disease progression assessed by investigator or death due to any cause
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Time from first subject dose to study completion, or up to 36 month
Disease control response (DcR)
Time frame: Time from first subject dose to study completion, or up to 36 month
Duration of Response (DoR)
Time frame: Time from first subject dose to study completion, or up to 36 month
Adverse events (AEs)
Time frame: From first dose to the last dose, up to 24 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing limertinib and etoposide and carboplatin in people with Small Cell Lung Cancer and Non Small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongchang zhang, MD (+8613873123436 ext. +8613873123436, zhangyongchang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Time from first subject dose to study completion, or up to 36 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.