Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Micronutrients

Hematinics

Vitamins

Pembrolizumab

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Antibodies

Antibodies, Monoclonal

Pemetrexed

Tislelizumab

Cisplatin

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Participants will receive ociperlimab in combination with tislelizumab and platinum-based doublet chemotherapy

Participants will receive ociperlimab placebo in combination with pembrolizumab and platinum-based doublet chemotherapy

Participants will receive ociperlimab placebo in combination with tislelizumab and platinum-based doublet chemotherapy

Ociperlimab is a monoclonal antibody formulated for intravenous infusion. 900 mg of ociperlimab will be administered on Day 1 of each 21-day cycle

Ociperlimab

Placebo infusions will consist of a sterile, normal saline solution. Placebo will be administered on Day 1 of each 21-day cycle

Placebo

Tislelizumab is a monoclonal antibody formulated for intravenous infusion. 200 mg of tislelizumab will be administered on Day 1 of each 21-day cycle

Pembrolizumab is a monoclonal antibody formulated for intravenous infusion. 200 mg of pembrolizumab will be administered on Day 1 of each 21-day cycle

Carboplatin is a chemotherapy agent formulated for intravenous infusion. Carboplatin will be administered (AUC 6 mg/mL\*min) on Day 1 of each 21-day cycle

Cisplatin is a chemotherapy agent formulated for intravenous infusion. Cisplatin will be administered (75 mg/m\^2) on Day 1 of each 21-day cycle

Pemetrexed is a chemotherapy agent formulated for intravenous infusion. Pemetrexed will be administered (500 mg/m\^2) on Day 1 of each 21-day cycle

Paclitaxel is a chemotherapy agent formulated for intravenous infusion. Paclitaxel will be administered (200 mg/m\^2) on Day 1 of each 21-day cycle

Nab-paclitaxel is a chemotherapy agent formulated for intravenous infusion. Nab-paclitaxel will be administered (100 mg/m\^2) on Day 1, 8 and 15 of each 21-day cycle

Nab-paclitaxel

Novartis Pharmaceuticals

The primary scientific question of interest is whether the addition of ociperlimab to platinum-based chemotherapy and tislelizumab improve progression-free survival (PFS) or overall survival (OS) compared to pembrolizumab and platinum-based chemotherapy as first-line therapy for participants with locally advanced or metastatic squamous or non-squamous NSCLC with PD-L1 expression of ≥1%.

This is a randomized, double-blind, placebo controlled, multicenter, phase III study evaluating the efficacy and safety of ociperlimab in combination with tislelizumab and platinum-based doublet chemotherapy as first-line treatment for participants with locally advanced or metastatic NSCLC without actionable driver mutations.

Participants will receive study treatment every three weeks and will continue to receive it until RECIST 1.1 disease progression as determined by Investigator and confirmed by BIRC, unacceptable toxicity that precludes further treatment, treatment is discontinued at the discretion of the Investigator or participant, participant withdrawal of consent, pregnancy, lost to follow-up, or death.

Study of Efficacy and Safety of Ociperlimab in Combination With Tislelizumab and Platinum-based Doublet Chemotherapy as First-line Treatment for Participants With Locally Advanced or Metastatic NSCLC.

AdvanTIG-306: A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Ociperlimab (WCD118/BGB-A1217) Combined With Tislelizumab (VDT482/BGB-A317) Plus Platinum-based Doublet Chemotherapy Versus Placebo Combined With Pembrolizumab Plus Platinum-based Doublet Chemotherapy as First-line Therapy for Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Time from date of randomization/start of treatment to the date of event defined as the first documented progression based on BIRC assessment as per RECIST 1.1 or death due to any cause in participants with PD-L1 expression in ≥1% of tumor cells, for participants in Arm A compared to Arm B

Time from date of randomization/start of treatment to date of death due to any cause in participants with PD-L1 expression in ≥1% of tumor cells, for participants in Arm A compared to Arm B

Time from date of randomization/start of treatment to the date of event defined as the first documented progression based on BIRC assessment as per RECIST 1.1 or death due to any cause in all participants in Arm A compared to Arm B

Time from date of randomization/start of treatment to date of death due to any cause in all participants in Arm A compared to Arm B.

Percentage of participants with best overall response of complete response (CR) or partial response (PR) based in BIRC assessment as per RECIST 1.1 in participants with PD-L1 expression ≥1% and in all participants randomized, for participants in Arm A compared to Arm B

Percentage of participants with best overall response of CR, PR or stable disease (SD)based in BIRC assessment as per RECIST 1.1 in participants with PD-L1 expression ≥1% and in all participants randomized, for participants in Arm A compared to Arm B

Time from the date of randomization to the date of first documented response (CR or PR) based in BIRC assessment as per RECIST 1.1 in participants with PD-L1 expression ≥1% and in all participants randomized, for participants in Arm A compared to Arm B

Time between the date of first documented response (CR or PR) and the date of first documented progression or death due to any cause based in BIRC assessment as per RECIST 1.1 in participants with PD-L1 expression ≥1% and in all participants randomized, for participants in Arm A compared to Arm B

Percentage of participants with best overall response of complete response (CR) or partial response (PR) based in BIRC assessment as per RECIST 1.1 in participants with PD-L1 expression ≥1% and in all participants randomized, for participants in Arm A compared to Arm C

Percentage of participants with best overall response of CR, PR or stable disease (SD)based in BIRC assessment as per RECIST 1.1 in participants with PD-L1 expression ≥1% and in all participants randomized, for participants in Arm A compared to Arm C

Time from the date of randomization to the date of first documented response (CR or PR) based in BIRC assessment as per RECIST 1.1 in participants with PD-L1 expression ≥1% and in all participants randomized, for participants in Arm A compared to Arm C

Time between the date of first documented response (CR or PR) and the date of first documented progression or death due to any cause based in BIRC assessment as per RECIST 1.1 in participants with PD-L1 expression ≥1% and in all participants randomized, for participants in Arm A compared to Arm C

Time from date of randomization/start of treatment to the date of event defined as the first documented progression based on BIRC assessment as per RECIST 1.1 or death due to any cause in participants with PD-L1 expression ≥1% and in all participants randomized, for participants in Arm A compared to Arm C

Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of ociperlimab and tislelizumab. AUClast will be summarized using descriptive statistics.

Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of ociperlimab and tislelizumab. Cmax will be summarized using descriptive statistics.

Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of ociperlimab and tislelizumab. Tmax will be summarized using descriptive statistics.

Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of ociperlimab and tislelizumab. Ctrough will be summarized using descriptive statistics.

Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of ociperlimab and tislelizumab. AUCtau will be summarized using descriptive statistics.

Prevalence of ADA (anti-ociperlimab, anti-tislelizumab) at baseline is defined as the percentage of participants who have an ADA positive result at baseline

Incidence of ADA (anti-ociperlimab, anti-tislelizumab) on treatment is defined as the percentage of participants who are treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted ADA positive (post-baseline ADA positive with titer that is at least the fold titer change greater than the ADA-positive baseline titer)

The EORTC QLQ-C30 is a questionnaire developed to assess the health-related quality of life of cancer participants. It assesses 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/quality of life (QoL) scale. All of the domain scores range from 0 to 100. A high score for a functional scale indicates a high and healthy level of functioning but a high score for a symptom scale indicates a high level of symptoms.

The time to definitive 10 point deterioration of physical functioning and role functioning is defined as the time from the date of randomization to first onset of ≥10 points increase from baseline (worsening) of the corresponding scale score, with no later change below this threshold or death due to any cause.

The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) is used in conjunction with the EORTC QLQ-C30 and provides information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporates one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores range from 0 to 100. A high score indicates a high level of symptoms.

The time to first 10 point deterioration symptom scores of chest pain, cough and dyspnea is defined as the time from the date of randomization to first onset of ≥10 points increase from baseline (worsening) of the corresponding scale score, with no later change below this threshold or death due to any cause.

The EORTC QLQ-C30 is a questionnaire developed to assess the health-related quality of life of cancer participants. It assesses 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/quality of life (QoL) scale. All of the domain scores range from 0 to 100. A high score for a functional scale indicates a high and healthy level of functioning but a high score for a symptom scale indicates a high level of symptoms.

The time to confirmed 10-point deterioration of physical functioning and role functioning is defined as the time from the date of randomization to first onset of≥10 points deterioration from baseline and confirmed by a second consecutive ≥10 points deterioration from baseline, or one assessment followed by death from any cause before the next scheduled data collection.

The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) is used in conjunction with the EORTC QLQ-C30 and provides information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporates one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores range from 0 to 100. A high score indicates a high level of symptoms.

The time to first 10 point deterioration symptom scores of chest pain, cough and dyspnea is defined as the time from the date of randomization to first onset of≥10 points deterioration from baseline and confirmed by a second consecutive ≥10 points deterioration from baseline, or one assessment followed by death from any cause before the next scheduled data collection.

The EORTC QLQ-C30 is a questionnaire developed to assess the health-related quality of life of cancer participants. It assesses 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/quality of life (QoL) scale. All of the domain scores range from 0 to 100. A high score for a functional scale indicates a high and healthy level of functioning but a high score for a symptom scale indicates a high level of symptoms.

The time to definitive 10-point deterioration in global health status/quality of life, shortness of breath and pain scores is defined as the time from the date of randomization to first onset of ≥10 points increase from baseline (worsening) of the corresponding scale score, with no later change below this threshold or death due to any cause.

EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions.

Time from date of randomization to the first documented progression on next line therapy or death from any cause, whichever occurs first

Time to definitive deterioration of the ECOG PS by one category of the score. The ECOG PS is a measure of functional status. It ranges from 0 to 5, with 0 denoting perfect health and 5 death. A deterioration is considered definitive if no improvements in the ECOG PS status is observed at any subsequent time of measurement during the treatment period following the time point where the deterioration is observed.

Spots Global Cancer Trial Database for Study of Efficacy and Safety of Ociperlimab in Combination With Tislelizumab and Platinum-based Doublet Chemotherapy as First-line Treatment for Participants With Locally Advanced or Metastatic NSCLC.

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