OncoMatch

OncoMatch/Clinical Trials/NCT05800340

Neoadjuvant Immunotherapy in Rare Mutations Localized NSCLC

Is NCT05800340 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Toripalimab and Nab paclitaxel for non-small cell lung cancer.

Phase 2RecruitingGuangdong Provincial People's HospitalNCT05800340Data as of May 2026

Treatment: Toripalimab · Nab paclitaxel · Pemetrexed · CarboplatinPhase II, single-arm, open-label single center study that assess clinical feasibility and safety of 3 cycles neoadjuvant Toripalimab plus chemotherapy in rare mutations stage IIB-IIIB NSCLC followed by optional adjuvant treatment upon investigators' decisions.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: RET fusion

rare driver alteration including RET fusions

Required: BRAF V600E

BRAF (V600E or non-V600E but confirmed driver mutations)

Required: BRAF non-V600E but confirmed driver mutations

BRAF (V600E or non-V600E but confirmed driver mutations)

Required: HER2 (ERBB2) exon20 insertion

ERBB2 exon20 insertion

Required: MET amplification (FISH confirmed)

MET amplification (FISH confirmed)

Required: MET exon 14 skipping

MET...exon 14 skipping

Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)

Available tissue of tumor for PD-L1 test

Excluded: EGFR sensitive alteration

Large panel NGS indicated sensitive EGFR alteration

Excluded: ALK fusion

Large panel NGS indicated...ALK fusion

Excluded: ROS1 fusion

Large panel NGS indicated...ROS1 fusion

Excluded: MDM2 amplification

any other driver mutations combined with MDM2/MDM4 amplification

Excluded: MDM4 amplification

any other driver mutations combined with MDM2/MDM4 amplification

Disease stage

Required: Stage IIB, IIIB

Excluded: Stage I, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: anti-tumor drugs

Patients who have previously used any other anti-tumor drugs or radiotherapy

Cannot have received: radiotherapy

Patients who have previously used any other anti-tumor drugs or radiotherapy

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

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