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

Exploring the Efficacy of Tislelizumab Combined With Albumin-bound Paclitaxel and Platinum-based Chemotherapy in Patients With KRAS-mutated Lung Cancer Who Are Ineligible for Curative Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07638878
Enrollment
30
Registered
2026-06-10
Start date
2020-11-06
Completion date
2028-12-01
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer (Locally Advanced or Metastatic)

Keywords

KRAS-mutated lung cancer

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

Interventions

DRUGtislelizumab in combination with nab-paclitaxel and platinum chemotherapy

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

Sponsors

Guangzhou Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Ages 18-75 years (inclusive), regardless of gender; 2. 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); 3. Or histologically confirmed inoperable mixed small cell lung cancer containing non-small cell lung cancer components; 4. KRAS gene mutation-positive; 5. KRAS mutation-positive lung cancer not amenable to radical surgery, treated with tislelizumab in combination with nab-paclitaxel and platinum chemotherapy.

Exclusion criteria

1. Patients with incomplete key baseline information and treatment data. 2. Patients who refuse to provide written informed consent (ICF).

Design outcomes

Primary

MeasureTime frameDescription
objective response rate (ORR)Up to approximately 2 yearsORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.

Secondary

MeasureTime frameDescription
Overall Survival (OS)Up to approximately 5 yearsThe time from the enrollment date until death from any cause.
AEUp to approximately 2 yearsAE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026