NCT05800340

Neoadjuvant Immunotherapy in Rare Mutations Localized NSCLC

Recruiting now Phase 2 Last updated 5 April 2023

What this trial tests

Phase 2 trial testing Toripalimab in Non-Small Cell Lung Cancer in 30 participants. Currently enrolling.

Timeline

4 April 2023

Primary endpoint
31 December 2024

31 December 2026

Quick facts

Lead sponsor	Guangdong Provincial People's Hospital
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	4 April 2023
Primary completion	31 December 2024
Estimated completion	31 December 2026
Sites	1 location across China

Drugs / interventions tested

• Toripalimab (TORIPALIMAB) — full drug profile →
• Nab paclitaxel
• Pemetrexed — full drug profile →
• Carboplatin (Carboplatin) — full drug profile →

Conditions studied

• Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →
• RET Driver Mutation — all drugs for RET Driver Mutation →
• BRAF V600 Mutation — all drugs for BRAF V600 Mutation →
• Erb-B2 Receptor Tyrosine Kinase Exon 20 Mutation — all drugs for Erb-B2 Receptor Tyrosine Kinase Exon 20 Mutation →

Sponsor

Guangdong Provincial People's Hospital

Who can join

18 and older, any sex, with Non-Small Cell Lung Cancer or RET Driver Mutation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. MET in Non-Small-Cell Lung Cancer (NSCLC): Cross 'a Long and Winding Road' Looking for a Target.
   Spitaleri G, Trillo Aliaga P, Attili I, Del Signore E, et al · · 2023 · cited 18× · PMID 37835473 · DOI 10.3390/cancers15194779
2. Navigating Therapeutic Challenges in BRAF-Mutated NSCLC: Non-V600 Mutations, Immunotherapy, and Overcoming Resistance.
   Bortolot M, Torresan S, De Carlo E, Bertoli E, et al · · 2024 · cited 2× · PMID 39684685 · DOI 10.3390/ijms252312972
3. Neoadjuvant, Perioperative, and Adjuvant Immunotherapy in Early-Stage Surgically Resectable Non-Small Cell Lung Cancer: Updates and Future Perspectives.
   Gathers D, Oswalt C, Alder L, Chen K, et al · · 2025 · cited 1× · PMID 40647378 · DOI 10.3390/cancers17132077
4. Conversion therapy with immunotherapy plus chemotherapy achieves a pathological complete response in stage IIIC NSCLC.
   Fu Y, Duan W, Xu R, Chen J. · · 2023 · cited 1× · PMID 38022567 · DOI 10.3389/fimmu.2023.1268153
5. Targeting rare oncogenic mutations in resectable non-small cell lung cancer: emerging perioperative strategies.
   Hao S, Zhao S, Shi L, Zhong L, et al · · 2026 · PMID 41816478 · DOI 10.21037/jtd-2025-aw-2202
6. Neoadjuvant, Adjuvant and Perioperative Treatment in Early-Stage Non-Small Cell Lung Cancer (NSCLC) with Actionable Genomic Alterations: Current Landscape and Future Perspectives.
   Koutoukoglou P, Mountzios G. · · 2026 · PMID 41681965 · DOI 10.3390/cancers18030493
7. Neoadjuvant tepotinib in stage IIB N0 non-small cell lung carcinoma with <i>MET</i> exon 14 skipping mutation: a case report and review of the literature.
   Reyes A, Pharaon R, Mohanty A, Kim J, et al · · 2025 · PMID 40535068 · DOI 10.21037/tlcr-2024-1197