Lung Cancer, Non-Small CellPhase 2NCT06659042
Perioperative Tislelizumab for Resectable II-IIIB(N2) KRAS-mutated Nonsquamous Non-small Cell Lung Cancer
A Phase 2 study testing Tislelizumab, Cisplatin and Carboplatin in people with Lung Cancer, Non-Small Cell, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
The primary objective of the perioperative study is to evaluate pathological complete response in resectable II-IIIB(N2) KRAS-mutated nonsquamous non-small cell lung cancer participants receiving tislelizumab plus platinum-based doublet chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-Small Cell
- What is being tested?
- Tislelizumab, Cisplatin and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2024to 20 Nov 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent (ICF) and able to understand and comply with the study requirements and assessment schedule.
- Male or female aged ≥18 years at the time of signing the ICF.
- Histologically or cytologically confirmed stage II-IIIB (N2) non-squamous non-small cell lung cancer (NSCLC) (AJCC 8th edition).
- With Known KRAS gene mutation.
- Evaluated by medical and surgical discussion to be eligible for R0 resection with curative intent prior to study enrollment.
- At least one measurable lesion as defined by RECIST v1.1.
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- Eligible to receive platinum-based doublet chemotherapy.
- ECOG performance status score ≤ 1.
- Adequate organ function during the screening period
- Good cardiopulmonary function, meeting the requirements for surgical resection with curative intent.
- Patients of childbearing potential must be willing to use effective contraception during the study and for 120 days after the last dose of tislelizumab.
Who cannot join
- Patients meeting any of the following criteria are not eligible for enrollment:
- Previously received any treatment for the current lung cancer, including radiotherapy and all systemic anti-tumor treatments, including chemotherapy, immunotherapy, targeted therapy, or anti-angiogenic therapy.
- Presence of locally advanced, unresectable disease, regardless of disease stage or presence of metastases.
- Received other approved systemic immunomodulatory agents (including but not limited to interferon, interleukin-2, tumor necrosis factor, thymosin α1, and thymalfasin) within 4 weeks prior to the first dose.
- Used any herbal medicine to control cancer within 14 days prior to the first dose of the study drug.
- Received live or attenuated live vaccines within 4 weeks prior to enrollment or expected to require live or attenuated live vaccines during the study or within 5 months after the last dose of tislelizumab.
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- Any condition requiring systemic corticosteroid therapy (prednisone or equivalent >10 mg/day) or other immunosuppressive therapy within 14 days prior to the first dose of the study drug, which the investigator believes may affect the study treatment.
- Active autoimmune disease requiring systemic treatment, which the investigator believes may affect the study treatment.
- Interstitial lung disease, non-infectious pneumonitis, or uncontrolled other diseases, including diabetes, pulmonary fibrosis, acute lung disease, etc., which the investigator believes may affect the study treatment.
- History of major diseases or clinical manifestations that may affect organ system function, which the investigator believes may affect the study treatment.
- Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral treatment within 14 days prior to the first dose of the study drug (including tuberculosis infection, etc.).
- Known history of human immunodeficiency virus (HIV) infection.
- Previously undergone allogeneic stem cell transplantation or organ transplantation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Feng Yao, 021-22200000-12345, xkyyGCP2021@163.com
Feng Yao
About this study
Official title: A Prospective, Single-arm Phase II Study of the Efficacy and Safety of Tislelizumab in Combination With Chemotherapy Perioperative Treatment for Resectable II-IIIB(N2) KRAS-mutated Nonsquamous Non-small Cell Lung Cancer
The primary objective of the perioperative study is to evaluate pathological complete response in resectable II-IIIB(N2) KRAS-mutated nonsquamous non-small cell lung cancer participants receiving tislelizumab plus platinum-based doublet chemotherapy.
- Conditions
- Lung Cancer, Non-Small Cell
- Being tested
- Tislelizumab, Cisplatin, Carboplatin, Pemetrexed Disodium
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
administered via Intravenous (IV) injection
CisplatinDrug
administered via IV infusion
CarboplatinDrug
administered via IV infusion
Pemetrexed DisodiumDrug
administered via IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab plus platinum doublet chemotherapy | Experimental | Not described Receives: Drug: Tislelizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed Disodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rate
Measured: Up to 3 months following completion of neoadjuvant treatment
Secondary outcomes (5)
Major pathological response (MPR) rate
Measured: Up to 3 months following completion of neoadjuvant treatment
Objective Response Rate (ORR)
Measured: Up to 3 years
Event-free survival (EFS)
Measured: Up to 3 years
Overall survival (OS)
Measured: Up to 3 years
Number of participants experiencing treatment-emergent adverse events (TEAEs)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start20 Nov 2024
- Primary completion20 Nov 2025 (estimated)
- Study completion20 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Non-Small CellStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Yao, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659042
- Sponsor's protocol ID
- 2024IIT-145
- Status last verified
- May 2025
- First submitted
- 23 Oct 2024
- Last updated
- 18 May 2025
- 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 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm Phase II Study of the Efficacy and Safety of Tislelizumab in Combination With Chemotherapy Perioperative Treatment for Resectable II-IIIB(N2) KRAS-mutated Nonsquamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06659042
- Acronym / sponsor ID
- 2024IIT-145
- Conditions
- Lung Cancer, Non-Small Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 20 Nov 2027 (estimated)
- First posted
- 26 Oct 2024 (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.
The primary objective of the perioperative study is to evaluate pathological complete response in resectable II-IIIB(N2) KRAS-mutated nonsquamous non-small cell lung cancer participants receiving tislelizumab plus platinum-based doublet chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab plus platinum doublet chemotherapy | Experimental | Drug: Tislelizumab, Drug: Cisplatin, Drug: Carboplatin, Drug: Pemetrexed Disodium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Able to provide written informed consent (ICF) and able to understand and comply with the study requirements and assessment schedule.
- Male or female aged ≥18 years at the time of signing the ICF.
- Histologically or cytologically confirmed stage II-IIIB (N2) non-squamous non-small cell lung cancer (NSCLC) (AJCC 8th edition).
- With Known KRAS gene mutation.
- Evaluated by medical and surgical discussion to be eligible for R0 resection with curative intent prior to study enrollment.
Key exclusion criteria (13 listed)
- Previously received any treatment for the current lung cancer, including radiotherapy and all systemic anti-tumor treatments, including chemotherapy, immunotherapy, targeted therapy, or anti-angiogenic therapy.
- Presence of locally advanced, unresectable disease, regardless of disease stage or presence of metastases.
- Received other approved systemic immunomodulatory agents (including but not limited to interferon, interleukin-2, tumor necrosis factor, thymosin α1, and thymalfasin) within 4 weeks prior to the first dose.
- Used any herbal medicine to control cancer within 14 days prior to the first dose of the study drug.
- Received live or attenuated live vaccines within 4 weeks prior to enrollment or expected to require live or attenuated live vaccines during the study or within 5 months after the last dose of tislelizumab.
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 |
|---|---|---|
| Tislelizumabadministered via Intravenous (IV) injection | Drug | Tislelizumab plus platinum doublet chemotherapy |
| Cisplatinadministered via IV infusion | Drug | Tislelizumab plus platinum doublet chemotherapy |
| Carboplatinadministered via IV infusion | Drug | Tislelizumab plus platinum doublet chemotherapy |
| Pemetrexed Disodiumadministered via IV infusion | Drug | Tislelizumab plus platinum doublet chemotherapy |
Primary outcome
Pathological complete response (pCR) rate
Time frame: Up to 3 months following completion of neoadjuvant treatment
5 secondary outcomes
Major pathological response (MPR) rate
Time frame: Up to 3 months following completion of neoadjuvant treatment
Objective Response Rate (ORR)
Time frame: Up to 3 years
Event-free survival (EFS)
Time frame: Up to 3 years
Overall survival (OS)
Time frame: Up to 3 years
Number of participants experiencing treatment-emergent adverse events (TEAEs)
Time frame: Up to 3 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 18 May 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab, Cisplatin and Carboplatin in people with Lung Cancer, Non-Small Cell, run by Shanghai Chest Hospital 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 11 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 18 May 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Feng Yao (021-22200000-12345, yaofeng@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) rate (time frame: Up to 3 months following completion of neoadjuvant treatment). 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 18 May 2025.