NCT04606303

A Phase Ⅱ Trial of Neoadjuvant Toripalimab Plus Platinum-doublet Chemotherapy in Locally Advanced NSCLC.

A Single-center, Prospective, Single-arm Phase Ⅱ Trial of Neoadjuvant Toripalimab Plus Platinum-doublet Chemotherapy in Locally Advanced NSCLC.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, prospective, single-arm, open-Label, single-center study that to find out (1)The effectiveness and safety of toripalimab combined with platinum-doublet chemotherapy as a preoperative neoadjuvant therapy for locally advanced (stage IIB, IIIA, and resectable stage IIIB) NSCLC, (2)The best treatment time for this combination of neoadjuvant therapy before surgery, (3)The effectiveness and safety of combination of neoadjuvant therapy as salvage neoadjuvant therapy after failure of neoadjuvant chemo-only for locally advanced non-small cell lung cancer.

Conditions

• Locally Advanced NSCLC

Interventions

Type	Name	Description
DRUG	Toripalimab combination with platinum-containing dual-drug chemotherapy.	cisplatin + paclitaxel/ albumin-bound paclitaxel/ gemcitabine/ Pemetroxel+ Toripalimab (cisplatin 75mg/m2 (D1), paclitaxel 175mg/m2 (D1), or albumin-bound paclitaxel 260mg/m2 (D1), or gemcitabine 1250mg/m2 (D1, D8), or Pemetroxel 500mg/m2 (D1)), Toripalimab 240mg D1, Q3W. If the patient is SD or PD, Toripalimab combined with platinum-containing dual-drug chemotherapy in the third cycle will continue, and a total of 4 cycles can be carried out at most, and the therapeutic effect will be evaluated after each cycle of treatment. If the patient is PR or CR at any time during the treatment (after treatment in the third or fourth cycle), the surgical treatment will be entered. If PR or CR is still not reached after treatment in the fourth cycle, the endpoint of the trial will be reached, theobservation of the patient will be finished, and the subsequent treatment will be decided by the clinician.

Timeline

• Start date: 2020-12-18
• Primary completion: 2023-05-21
• Completion: 2024-05-01
• First posted: 2020-10-28
• Last updated: 2023-04-05

Locations

1 site across 1 country: China