OncoMatch/Clinical Trials/NCT05800340
Neoadjuvant Immunotherapy in Rare Mutations Localized NSCLC
Is NCT05800340 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Toripalimab and Nab paclitaxel for non-small cell lung cancer.
Treatment: Toripalimab · Nab paclitaxel · Pemetrexed · Carboplatin — Phase 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
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
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.
Frequently asked questions
Is NCT05800340 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require RET?
Yes, RET fusion is a required biomarker for enrollment.
Does this trial require BRAF?
Yes, BRAF V600E is a required biomarker for enrollment.
Does this trial require BRAF?
Yes, BRAF non-V600E but confirmed driver mutations is a required biomarker for enrollment.
Are patients with EGFR alterations eligible?
No. EGFR sensitive alteration is an exclusion criterion.
Are patients with ALK alterations eligible?
No. ALK fusion is an exclusion criterion.
What disease stage is eligible?
Stage IIB or IIIB is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify