Lung Cancer (Locally Advanced or Metastatic)NCT07638878
The Efficacy of Tislelizumab Combined With Albumin-bound Paclitaxel and Platinum-based Chemotherapy in Patients With KRAS-mutated Lung Cancer
An observational study of Lung Cancer (Locally Advanced or Metastatic), run by Guangzhou Medical University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer (Locally Advanced or Metastatic)
- What is being tested?
- tislelizumab in combination with nab-paclitaxel and platinum chemotherapy
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2020to Dec 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Patients with incomplete key baseline information and treatment data.
- Patients who refuse to provide written informed consent (ICF).
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
About this study
Official 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
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
- Being tested
- tislelizumab in combination with nab-paclitaxel and platinum chemotherapy
- Keywords
- KRAS-mutated lung cancer
- Medical subject headings
- Lung Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tislelizumab in combination with nab-paclitaxel and platinum chemotherapyDrug
Unresectable KRAS mutation-positive lung cancer receiving tislelizumab plus nab-paclitaxel and platinum-based chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: tislelizumab in combination with nab-paclitaxel and platinum chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.
Measured: Up to approximately 2 years
Secondary outcomes (2)
Overall Survival (OS)
The time from the enrollment date until death from any cause.
Measured: Up to approximately 5 years
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.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start6 Nov 2020
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Locally Advanced or Metastatic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haihong Yang, MD, Pricipal investigator, Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638878
- Sponsor's protocol ID
- TCAP
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07638878
- Acronym / sponsor ID
- TCAP
- Keywords
- KRAS-mutated lung cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KRAS-mutated lung cancer | – | Drug: tislelizumab in combination with nab-paclitaxel and platinum chemotherapyKRAS mutation-positive lung cancer not amenable to radical surgery, treated with tislelizumab in combination with nab-paclitaxel and platinum chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with incomplete key baseline information and treatment data.
- Patients who refuse to provide written informed consent (ICF).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tislelizumab in combination with nab-paclitaxel and platinum chemotherapyUnresectable KRAS mutation-positive lung cancer receiving tislelizumab plus nab-paclitaxel and platinum-based chemotherapy | Drug | KRAS-mutated lung cancer |
Primary outcome
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.
2 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 5 years
AE
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (Locally Advanced or Metastatic), run by Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (ORR) (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.