The Efficacy of Tislelizumab Combined With Albumin-bound Paclitaxel and Platinum-based Chemotherapy in Patients With KRAS-mutated Lung Cancer

NCT07638878 | Active Not Recruiting

• 1 other identifier: TCAP
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the optimal objective response rate (ORR) of tislelizumab combined with albumin-bound paclitaxel and platinum agents in patients with KRAS-mutant lung cancer who are ineligible for curative surgery

Conditions

Lung Cancer (Locally Advanced or Metastatic)

Keywords

KRAS-mutated lung cancer

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR)

  ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.

  Up to approximately 2 years

Secondary Outcomes (2)

• Overall Survival (OS)

  Up to approximately 5 years

• AE

  Up to approximately 2 years

Study Arms (1)

KRAS-mutated lung cancer

KRAS mutation-positive lung cancer not amenable to radical surgery, treated with tislelizumab in combination with nab-paclitaxel and platinum chemotherapy

Drug: tislelizumab in combination with nab-paclitaxel and platinum chemotherapy

Interventions

tislelizumab in combination with nab-paclitaxel and platinum chemotherapy DRUG

Unresectable KRAS mutation-positive lung cancer receiving tislelizumab plus nab-paclitaxel and platinum-based chemotherapy

KRAS-mutated lung cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with KRAS-mutant, non-small cell lung cancer (NSCLC) who are ineligible for curative surgery; or patients with mixed small cell lung cancer (SCLC) containing an NSCLC component

You may qualify if:

• Ages 18-75 years (inclusive), regardless of gender;
• Locally advanced (Stage IIIB, IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) confirmed by histology as inoperable for curative intent (according to the 8th edition of the IASLC TNM staging system);
• Or histologically confirmed inoperable mixed small cell lung cancer containing non-small cell lung cancer components;
• KRAS gene mutation-positive;
• KRAS mutation-positive lung cancer not amenable to radical surgery, treated with tislelizumab in combination with nab-paclitaxel and platinum chemotherapy.

You may not qualify if:

• Patients with incomplete key baseline information and treatment data.
• Patients who refuse to provide written informed consent (ICF).

Sponsors & Collaborators

• Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm Metastasis

Interventions

tislelizumab; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start: November 6, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)