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OncoMatch/Clinical Trials/NCT04136535

Pemetrexed and Carboplatin With or Without Anlotinib Hydrochloride for Osimertinib-resistant Non-squamous NSCLC

Is NCT04136535 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Pemetrexed and Carboplatin for nsclc stage iv.

Phase 2RecruitingFudan UniversityNCT04136535Data as of Jun 2026Location: China

Treatment: Pemetrexed · Carboplatin · AnlotinibEvaluate the efficacy and safety of Anlotinib Hydrochloride in combination with Pemetrexed and Carboplatin versus Pemetrexed and Carboplatin for advanced or locally-advanced Osimertinib-resistant non-squamous non-small cell lung cancer.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Anlotinib

Chemotherapy

PemetrexedCarboplatin

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR activating mutation

Disease stage

Required: Stage III, IV

locally advanced and / or metastatic non-squamous non-small cell lung cancer (NSCLC)

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

Min 1 prior line

Must have received: EGFR tyrosine kinase inhibitor (osimertinib)

previously disease progression to Osimertinib (previously treated with 1st / 2nd generation EGFR-TKI or not)

Cannot have received: systemic anti-tumor therapy

Planned for systemic anti-tumor therapy during the study period or within 4 weeks prior to enrollment, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or use mitomycin C within 6 weeks prior to receiving investigational drug).

Cannot have received: radiation therapy

Radiation-rehabilitation radiotherapy (EF-RT) was performed within 4 weeks before enrollment or limited-field radiotherapy was performed for planned tumor lesions within 2 weeks before enrollment.

Lab requirements

Blood counts

hemoglobin (HB) ≥90g/L; neutrophil absolute (ANC) ≥1.5×10^9/L; platelet (PLT) ≥80×10^9/L

Kidney function

serum creatinine (Cr) ≤1.25x ULN or creatinine clearance (CCr)≥45mL/min

Liver function

total bilirubin (TBIL) ≤1.5x ULN; ALT and AST ≤2.5x ULN, if liver metastasis occurred, ALT and AST ≤5x ULN

Cardiac function

LVEF <50% excluded; myocardial ischemia or infarction above grade II, poorly controlled arrhythmias (including men with QTc ≥ 450 ms, women ≥ 470 ms); NYHA III-IV excluded

Blood routine examination criteria... Biochemical tests meet the following criteria... cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) <50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT04136535 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior systemic anti-tumor therapy, radiation therapy disqualifies patients from enrollment.

Does this trial require EGFR?

Yes, EGFR activating mutation is a required biomarker for enrollment.

What disease stage is eligible?

Stage III or IV is required.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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