Non-Small Cell Lung CancerPhase 2NCT06475755
Neoadjuvant/Adjuvant Tislelizumab Combined With Anlotinib and Platinum Doublet Chemotherapy With Resectable NSCLC
A Phase 2 study testing Immunochemotherapy combined with antiangiogenic and Immunochemotherapy in people with Non-Small Cell Lung Cancer and Anti Angiogenesis, run by Tang-Du Hospital at 1 site in China.
Trial summary
This is a Phase II, prospective, randomized, open label, controlled, multi-center study, aim to evaluate the activity of Tislelizumab and Anlotinib and chemotherapy compared with Tislelizumab and chemotherapy before surgery, followed by Tislelizumab alone as adjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer, Anti Angiogenesis
- What is being tested?
- Immunochemotherapy combined with antiangiogenic and Immunochemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2024to 31 Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18~75 years old
- histologically confirmed stage IIA to stage IIIB (IIIB term T2/3/4N2) non-small cell lung cancer (staging based on AJCC 9th edition)
- ECOG PS score of 0-1;
- patients are asked to provide an archived tumor tissue sample (FFPE tissue block or approximately ≥ 6 freshly cut unstained FFPE sections) and a pathology report of this baseline sample for PD-L1 and other biomarker analysis). Biopsy samples are requested at baseline if there are no available archival samples or samples are unavailable.
- Adequate organ and marrow function
- expected survival ≥ 3 months;
- be evaluated by a thoracic surgeon and confirmed to be eligible for R0 resection for the purpose of radical treatment
- At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline
Who cannot join
- those with a known history of CNS metastases;
- patients with EGFR mutations or ALK translocations;
- those with imaging (CT or MRI) showing tumor invasion of a major blood vessel (e.g., pulmonary artery or superior vena cava) or those with a high likelihood of fatal hemorrhage due to tumor invasion of a major blood vessel during the follow-up study;
- prior treatment with immune checkpoint inhibitors, including but not limited to anti-CTLA-4, anti-PD-1 and anti-PD-L1 therapeutic antibodies, and OX-40;
- previous systemic antivascular therapy;
- current participation in an interventional clinical trial or receipt of another investigational drug or medical intervention within 4 weeks;
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- presence of active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction (or other factors affecting the absorption of oral medications such as inability to swallow, nausea and vomiting, abnormal physiologic function, malabsorption syndrome, etc.) that require clinical intervention
- the presence of any signs or history of bleeding constitution; the presence of unhealed wounds, ulcers, or fractures in patients who have experienced any bleeding or hemorrhagic event ≥ CTCAE Grade 3 within 4 weeks prior to enrollment;
- class III-IV congestive heart failure with poorly controlled and clinically significant arrhythmias (including QTcF ≥450ms in men and ≥470ms in women);
- difficult-to-control hypertension;
- history of severe allergy to anlotinib or its prophylactic agents;
- any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient cerebral ischemic attack, that has occurred within 6 months prior to enrollment in therapy
- patients whose medical history or test results indicate a hereditary predisposition to bleeding or coagulation disorders that may increase the risk of bleeding
- active autoimmune disease requiring systemic treatment or history of autoimmune disease with potential for relapse
- patients requiring long-term systemic glucocorticosteroids (patients requiring inhaled or locally injected glucocorticosteroids due to COPD, asthma may be enrolled) or who have received immunosuppressive therapy within 7 days prior to treatment
- have an active infection requiring treatment or have used systemic anti-infective medications within one week prior to the first dose;
- a history of interstitial lung disease, non-infectious pneumonia, or poorly controlled disease, including pulmonary fibrosis, acute lung disease
- a known history of human immunodeficiency virus (HIV) infection, untreated active hepatitis B (defined as HBsAg positivity along with a detectable HBV-DNA copy number greater than 2,000 IU/ml, and active HCV-infected subjects (HCV antibody positivity with HCV-RNA levels above the lower limit of detection);
- previous allogeneic stem cell transplantation or organ transplantation.
- have received a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1);
- pregnant or lactating women;
- patients with hypersensitivity to the study drug or excipients;
- history or evidence of disease that may interfere with the results of the trial, prevent the subject from participating in the study in its entirety, abnormal values of therapeutic or laboratory tests, or other conditions that, in the opinion of the investigator, make enrollment inappropriate The investigator believes that there are other potential risks that make participation in the study inappropriate;
- stage IIIB exclusion of patients with TxN3 non-small cell lung cancer (staging based on AJCC 9th edition);
- renal insufficiency: routine urinalysis suggestive of urinary protein ≥++ or confirmed 24-hour urinary protein volume ≥1.0 g;
- patients with central squamous cell carcinoma confirmed by imaging and pathology;
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
Tangdu Hospital of the Fourth Millitary Medical University
Xi'an, Shaanxi, 710000
Xiaolong Yan, MD, 8615991269383, yanxiaolong@fmmu.edu.cn
About this study
Official title: A Phase II, Prospective, Randomized, Open Label, Multi-center Study of Tislelizumab Combined With Anlotinib and Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant With Resectable Stage II-IIIB Non-Small Cell Lung Cancer
This is a Phase II, prospective, randomized, open label, controlled, multi-center study, aim to evaluate the activity of Tislelizumab and Anlotinib and chemotherapy compared with Tislelizumab and chemotherapy before surgery, followed by Tislelizumab alone as adjuvant therapy. The primary objective of this study is to evaluate and compare pathological complete response rate(pCR).
- Conditions
- Non-Small Cell Lung Cancer, Anti Angiogenesis
- Being tested
- Immunochemotherapy combined with antiangiogenic, Immunochemotherapy
- 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.
Immunochemotherapy combined with antiangiogenicDrug
Also called Tislelizumab, Anlotinib, Cisplatin, Carboplatin
neoadjuvant： Tislelizumab 200mg iv，d1，q3w， Anlotinib 10mg，po，qd1-14，q3w， Cisplatin 75 mg/m^2 by IV infusion Q3W, given on cycle day 1 Carboplatin AUC of 5 on Day 1 of each 3-week cycle Paclitaxel 175mg/m2 on Day 1 of each 3-week cycle(SQ only) Albumin-bound paclitaxel 260mg/m2，on D1 IV infusion Q3W or 130mg/m2 on D1D8 IV infusion Q3W for each cycle(SQ only) Pemetrexed 500 mg/m2 on Day 1 of each 3-week cycle(NSQ only) Adjuvant: 4 weeks(±7 Days) following surgery, participants receive no more than 16 cycles (cycle length: 3 weeks) of Tislelizumab [200 mg, IV; given on cycle day 1].
ImmunochemotherapyDrug
Also called Tislelizumab, Cisplatin, Carboplatin, Paclitaxel
neoadjuvant：Tislelizumab 200mg iv，d1，q3w， Cisplatin 75 mg/m^2 by IV infusion Q3W, given on cycle day 1 Carboplatin AUC of 5 on Day 1 of each 3-week cycle Paclitaxel 175mg/m2 on Day 1 of each 3-week cycle(SQ only) Albumin-bound paclitaxel 260mg/m2，on D1 IV infusion Q3W or 130mg/m2 on D1D8 IV infusion Q3W for each cycle(SQ only) Pemetrexed 500 mg/m2 on Day 1 of each 3-week cycle(NSQ only) Adjuvant: 4 weeks(±7 Days) following surgery, participants receive no more than 16 cycles (cycle length: 3 weeks) of Tislelizumab [200 mg, IV; given on cycle day 1].
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab with anlotinib and platinum-based chemotherapy + Adjuvant Tislelizumab | Experimental | Intervention/treatment:
Tislelizumab 200mg iv，d1，q3w， Anlotinib 10mg，po，qd1-14，q3w， Cisplatin 75 mg/m^2 by IV infusion Q3W, given on cycle day 1 Carboplatin AUC of 5 on Day 1 of each 3-week cycle Paclitaxel 175mg/m2 on Day 1 of each 3-week cycle(SQ only) Albumin-bound paclitaxel 260mg/m2，on D1 IV infusion Q3W or 130mg/m2 on D1D8 IV infusion Q3W for each cycle(SQ only) Pemetrexed 500 mg/m2 on Day 1 of each 3-week cycle(NSQ only) Adjuvant: 4 weeks(±7 Days) following surgery, participants receive no more than 16 cycles (cycle length: 3 weeks) of Tislelizumab [200 mg, IV; given on cycle day 1]. Receives: Drug: Immunochemotherapy combined with antiangiogenic |
| Tislelizumab with platinum-based chemotherapy + Adjuvant Tislelizumab | Other | Tislelizumab 200mg iv，d1，q3w， Cisplatin 75 mg/m^2 by IV infusion Q3W, given on cycle day 1 Carboplatin AUC of 5 on Day 1 of each 3-week cycle Paclitaxel 175mg/m2 on Day 1 of each 3-week cycle(SQ only) Albumin-bound paclitaxel 260mg/m2，on D1 IV infusion Q3W or 130mg/m2 on D1D8 IV infusion Q3W for each cycle(SQ only) Pemetrexed 500 mg/m2 on Day 1 of each 3-week cycle(NSQ only) Adjuvant: 4 weeks(±7 Days) following surgery, participants receive no more than 16 cycles (cycle length: 3 weeks) of Tislelizumab [200 mg, IV; given on cycle day 1]. Receives: Drug: Immunochemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response (pCR) in Intent-to-Treat (ITT) analysis set
pathological complete response (pCR): defined as no residual tumor cells in the surgically resected tumor specimen and all sampled regional lymph nodes after neoadjuvant treatment.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start30 Jun 2024 (estimated)
- Primary completion10 Jun 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Tang-Du 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linna Liu, Study director, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475755
- Sponsor's protocol ID
- NO.202405-11
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Prospective, Randomized, Open Label, Multi-center Study of Tislelizumab Combined With Anlotinib and Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant With Resectable Stage II-IIIB Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06475755
- Acronym / sponsor ID
- NO.202405-11
- Conditions
- Non-Small Cell Lung Cancer, Anti Angiogenesis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 10 Jun 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Jun 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.
This is a Phase II, prospective, randomized, open label, controlled, multi-center study, aim to evaluate the activity of Tislelizumab and Anlotinib and chemotherapy compared with Tislelizumab and chemotherapy before surgery, followed by Tislelizumab alone as adjuvant therapy. The primary objective of this study is to evaluate and compare pathological complete response rate(pCR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab with anlotinib and platinum-based chemotherapy + Adjuvant Tislelizumab | Experimental | Drug: Immunochemotherapy combined with antiangiogenicIntervention/treatment: Tislelizumab 200mg iv，d1，q3w， Anlotinib 10mg，po，qd1-14，q3w， Cisplatin 75 mg/m^2 by IV infusion Q3W, given on cycle day 1 Carboplatin AUC of 5 on Day 1 of each 3-week cycle Paclitaxel 175mg/m2 on Day 1 of each 3-week cycle(SQ only) Albumin-bound paclitaxel 260mg/m2，on D1 IV infusion Q3W or 130mg/m2 on D1D8 IV infusion Q3W for each cycle(SQ only) Pemetrexed 500 mg/m2 on Day 1 of each 3-week cycle(NSQ only) Adjuvant: 4 weeks(±7 Days) following surgery, participants receive no more than 16 cycles (cycle length: 3 weeks) of Tislelizumab [200 mg, IV; given on cycle day 1]. |
| Tislelizumab with platinum-based chemotherapy + Adjuvant Tislelizumab | Other | Drug: ImmunochemotherapyTislelizumab 200mg iv，d1，q3w， Cisplatin 75 mg/m^2 by IV infusion Q3W, given on cycle day 1 Carboplatin AUC of 5 on Day 1 of each 3-week cycle Paclitaxel 175mg/m2 on Day 1 of each 3-week cycle(SQ only) Albumin-bound paclitaxel 260mg/m2，on D1 IV infusion Q3W or 130mg/m2 on D1D8 IV infusion Q3W for each cycle(SQ only) Pemetrexed 500 mg/m2 on Day 1 of each 3-week cycle(NSQ only) Adjuvant: 4 weeks(±7 Days) following surgery, participants receive no more than 16 cycles (cycle length: 3 weeks) of Tislelizumab [200 mg, IV; given on cycle day 1]. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- aged 18~75 years old
- histologically confirmed stage IIA to stage IIIB (IIIB term T2/3/4N2) non-small cell lung cancer (staging based on AJCC 9th edition)
- ECOG PS score of 0-1;
- patients are asked to provide an archived tumor tissue sample (FFPE tissue block or approximately ≥ 6 freshly cut unstained FFPE sections) and a pathology report of this baseline sample for PD-L1 and other biomarker analysis). Biopsy samples are requested at baseline if there are no available archival samples or samples are unavailable.
- Adequate organ and marrow function
Key exclusion criteria (26 listed)
- those with a known history of CNS metastases;
- patients with EGFR mutations or ALK translocations;
- those with imaging (CT or MRI) showing tumor invasion of a major blood vessel (e.g., pulmonary artery or superior vena cava) or those with a high likelihood of fatal hemorrhage due to tumor invasion of a major blood vessel during the follow-up study;
- prior treatment with immune checkpoint inhibitors, including but not limited to anti-CTLA-4, anti-PD-1 and anti-PD-L1 therapeutic antibodies, and OX-40;
- previous systemic antivascular therapy;
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 |
|---|---|---|
| Immunochemotherapy combined with antiangiogenicAlso: Tislelizumab, Anlotinib, Cisplatin, Carboplatinneoadjuvant： Tislelizumab 200mg iv，d1，q3w， Anlotinib 10mg，po，qd1-14，q3w， Cisplatin 75 mg/m^2 by IV infusion Q3W, given on cycle day 1 Carboplatin AUC of 5 on Day 1 of each 3-week cycle Paclitaxel 175mg/m2 on Day 1 of each 3-week cycle(SQ only) Albumin-bound paclitaxel 260mg/m2，on D1 IV infusion Q3W or 130mg/m2 on D1D8 IV infusion Q3W for each cycle(SQ only) Pemetrexed 500 mg/m2 on Day 1 of each 3-week cycle(NSQ only) Adjuvant: 4 weeks(±7 Days) following surgery, participants receive no more than 16 cycles (cycle length: 3 weeks) of Tislelizumab [200 mg, IV; given on cycle day 1]. | Drug | Tislelizumab with anlotinib and platinum-based chemotherapy + Adjuvant Tislelizumab |
| ImmunochemotherapyAlso: Tislelizumab, Cisplatin, Carboplatin, Paclitaxelneoadjuvant：Tislelizumab 200mg iv，d1，q3w， Cisplatin 75 mg/m^2 by IV infusion Q3W, given on cycle day 1 Carboplatin AUC of 5 on Day 1 of each 3-week cycle Paclitaxel 175mg/m2 on Day 1 of each 3-week cycle(SQ only) Albumin-bound paclitaxel 260mg/m2，on D1 IV infusion Q3W or 130mg/m2 on D1D8 IV infusion Q3W for each cycle(SQ only) Pemetrexed 500 mg/m2 on Day 1 of each 3-week cycle(NSQ only) Adjuvant: 4 weeks(±7 Days) following surgery, participants receive no more than 16 cycles (cycle length: 3 weeks) of Tislelizumab [200 mg, IV; given on cycle day 1]. | Drug | Tislelizumab with platinum-based chemotherapy + Adjuvant Tislelizumab |
Primary outcome
pathological complete response (pCR) in Intent-to-Treat (ITT) analysis set
Time frame: through study completion, an average of 1 year
pathological complete response (pCR): defined as no residual tumor cells in the surgically resected tumor specimen and all sampled regional lymph nodes after neoadjuvant treatment.
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 26 Jun 2024.
- 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.
Linna Liu study director
Tang-Du Hospital
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 Immunochemotherapy combined with antiangiogenic and Immunochemotherapy in people with Non-Small Cell Lung Cancer and Anti Angiogenesis, run by Tang-Du 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 8 inclusion and 26 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: opening soon, as of the sponsor's last update on 26 Jun 2024. 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 Xiaolong Yan (8615991269383, yanxiaolong@fmmu.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) in Intent-to-Treat (ITT) analysis set (time frame: through study completion, an average of 1 year). 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 26 Jun 2024.