Lung Cancer (Locally Advanced or Metastatic)
Conditions
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
Unresectable KRAS mutation-positive lung cancer receiving tislelizumab plus nab-paclitaxel and platinum-based chemotherapy
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| objective response rate (ORR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to approximately 5 years | The time from the enrollment date until death from any cause. |
| AE | 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. |
Countries
China