Neoadjuvant/Adjuvant Tislelizumab Combined With Anlotinib and Platinum Doublet Chemotherapy With Resectable NSCLC

NCT06475755 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: NO.202405-11
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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. The primary objective of this study is to evaluate and compare pathological complete response rate(pCR).

Conditions

Non-Small Cell Lung Cancer; Anti Angiogenesis

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 1 year

Study Arms (2)

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 \[200 mg, IV; given on cycle day 1\].

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 \[200 mg, IV; given on cycle day 1\].

Drug: Immunochemotherapy

Interventions

Immunochemotherapy combined with antiangiogenic DRUG

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 \[200 mg, IV; given on cycle day 1\].

Also known as: Tislelizumab, Anlotinib, Cisplatin, Carboplatin, Paclitaxel, Albumin-bound paclitaxel, Pemetrexed

Tislelizumab with anlotinib and platinum-based chemotherapy + Adjuvant Tislelizumab

Immunochemotherapy DRUG

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 \[200 mg, IV; given on cycle day 1\].

Also known as: Tislelizumab, Cisplatin, Carboplatin, Paclitaxel, Albumin-bound paclitaxel, Pemetrexed

Tislelizumab with platinum-based chemotherapy + Adjuvant Tislelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital of the Fourth Millitary Medical University

Xi'an, Shaanxi, 710000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Angiogenesis Inhibitors; tislelizumab; anlotinib; Cisplatin; Carboplatin; Paclitaxel; Albumin-Bound Paclitaxel; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Growth Inhibitors; Antineoplastic Agents; Therapeutic Uses; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic

Study Officials

• Linna Liu

  Tang-Du Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiaolong Yan

CONTACT

8615991269383; yanxiaolong@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 26, 2024
• Study Start: June 30, 2024
• Primary Completion: June 10, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)