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Active, not recruitingNCT07638878Updated Jun 10, 2026

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

An observational study in Lung Cancer (Locally Advanced or Metastatic), sponsored by Guangzhou Medical University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by Guangzhou Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
30
Ages
18 Years to 75 Years
Sex
All
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Study 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

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Conditions studied

  • Lung Cancer (Locally Advanced or Metastatic)

Keywords

  • KRAS-mutated lung cancer
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 30 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Guangzhou Medical University is the lead sponsor of 38 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Other
Enrollment
30 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • 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

  • Drugtislelizumab in combination with nab-paclitaxel and platinum chemotherapy

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

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What researchers measure

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.

    Time frame: Up to approximately 2 years

Secondary outcomes

  1. Overall Survival (OS)

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

    Time frame: Up to approximately 5 years

  2. AE

    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.

    Time frame: Up to approximately 2 years

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Study locations

1 site
  • The First Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07638878
Lead sponsor
Guangzhou Medical University
Responsible party
Haihong Yang, MD, Pricipal investigator (Chief Physician, Guangzhou Medical University) — Principal investigator
First posted
Jun 10, 2026
Start date
Nov 6, 2020
Primary completion
Dec 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jun 10, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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