NCT04541251

Neoadjuvant Camrelizumab, Nab-paclitaxel and Carboplatin in Stage IB-IIIA NSCLC

Status unknown Phase 2 Last updated 23 June 2021

What this trial tests

Phase 2 trial testing Camrelizumab + Nab-paclitaxel + Carboplatin in Lung Cancer, Non-small Cell in 40 participants. Status unknown.

Timeline

1 August 2020

Primary endpoint
30 July 2022

30 September 2023

Quick facts

Lead sponsor	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 August 2020
Primary completion	30 July 2022
Estimated completion	30 September 2023
Sites	1 location across China

Drugs / interventions tested

• Camrelizumab + Nab-paclitaxel + Carboplatin — full drug profile →

Conditions studied

• Lung Cancer, Non-small Cell — all drugs for Lung Cancer, Non-small Cell →
• Artificial Intelligence — all drugs for Artificial Intelligence →

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Who can join

18 and older, any sex, with Lung Cancer, Non-small Cell or Artificial Intelligence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This prospective, single-arm, multicenter, phase II trial enrolled 40 patients who underwent surgery after three cycles of neoadjuvant therapy with camrelizumab, nab-paclitaxel, and carboplatin. The MPR is the primary endpoint, and the pCR, the complete resection rate, the objective response rate, the disease-free survival, adverse events, and quality of life are the secondary endpoints. The exploratory endpoints will be used to establish a multiomics artificial intelligence system for neoadjuvant therapy effect prediction and decision-making assistance based on radiomics, metabolism, genetic, and clinic-pathological characteristics and to explore drug resistance mechanisms.

Publications & conference data

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

1. Tumor immunotherapies by immune checkpoint inhibitors (ICIs); the pros and cons.
   Naimi A, Mohammed RN, Raji A, Chupradit S, et al · · 2022 · cited 350× · PMID 35392976 · DOI 10.1186/s12964-022-00854-y
2. Neoadjuvant immunotherapy for non-small cell lung cancer: State of the art.
   Kang J, Zhang C, Zhong WZ. · · 2021 · cited 121× · PMID 33689225 · DOI 10.1002/cac2.12153
3. Tribulations and future opportunities for artificial intelligence in precision medicine.
   Carini C, Seyhan AA. · · 2024 · cited 67× · PMID 38702711 · DOI 10.1186/s12967-024-05067-0
4. Emerging precision neoadjuvant systemic therapy for patients with resectable non-small cell lung cancer: current status and perspectives.
   Godoy LA, Chen J, Ma W, Lally J, et al · · 2023 · cited 34× · PMID 36650586 · DOI 10.1186/s40364-022-00444-7
5. New strategies for lung cancer diagnosis and treatment: applications and advances in nanotechnology.
   Feng J, Zhang P, Wang D, Li Y, et al · · 2024 · cited 26× · PMID 39533445 · DOI 10.1186/s40364-024-00686-7
6. The Role of Radiomics in the Era of Immune Checkpoint Inhibitors: A New Protagonist in the Jungle of Response Criteria.
   Castello A, Castellani M, Florimonte L, Urso L, et al · · 2022 · cited 20× · PMID 35330068 · DOI 10.3390/jcm11061740
7. Neoadjuvant therapy in non-small cell lung cancer: basis, promise, and challenges.
   Kalvapudi S, Vedire Y, Yendamuri S, Barbi J. · · 2023 · cited 19× · PMID 38144524 · DOI 10.3389/fonc.2023.1286104
8. Expert consensus on perioperative immunotherapy for local advanced non-small cell lung cancer.
   Qiu B, Cai K, Chen C, Chen J, et al · · 2021 · cited 17× · PMID 34733623 · DOI 10.21037/tlcr-21-634