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Active, Not Recruiting

NCT Number: NCT07638878

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Lung Cancer (Locally Advanced or Metastatic) Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. objective response rate (ORR)

    Time frame: Up to approximately 2 years

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

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 5 years

    The time from the enrollment date until death from any cause.

  2. AE

    Time frame: Up to approximately 2 years

    AE 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.

Sponsors and collaborators

Lead sponsor

Guangzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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