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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 (May 2026). This Phase 2 trial studies multiple treatments including Pemetrexed and Carboplatin for nsclc stage iv.

Phase 2RecruitingFudan UniversityNCT04136535Data as of May 2026

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

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)

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.

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