Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Micronutrients

Hematinics

Vitamins

Antibodies

Antibodies, Monoclonal

Paclitaxel

Carboplatin

Pemetrexed

Pembrolizumab

Albumin-Bound Paclitaxel

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

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 carboplatin, pemetrexed, and paclitaxel by intravenous (IV) infusion.

Participants will receive zimberelimab monotherapy by IV infusion.

Participants will receive zimberelimab in combination with AB154 by IV infusion.

Participants will receive domvanalimab in combination with zimberelimab by IV infusion.

Participants will receive pembrolizumab by IV infusion.

Domvanalimab is a humanized monoclonal antibody targeting human TIGIT

Domvanalimab

Zimberelimab is a fully human anti-PD-1 monoclonal antibody

Zimberelimab

Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.

Pembrolizumab is a humanized Immunoglobulin G4 monoclonal antibody targeting the PD-1 receptor

Medical Director

This is a phase 3 study to evaluate zimberelimab (AB122) combined with domvanalimab (AB154) compared to pembrolizumab in front-line, PD-L1-high, locally advanced or metastatic NSCLC.

Study Comparing the Combination Domvanalimab and Zimberelimab With Pembrolizumab in Untreated Locally Advanced or Metastatic PD-L1-High Non-Small Cell Lung Cancer

A Phase 3 Study to Evaluate Zimberelimab (AB122) Combined With AB154 in Front-Line, PD-L1-High, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

For more information, please visit our website.

Arm D vs. Arm E - PFS as assessed by RECIST v1.1 by blinded independent central review

Arm D vs. Arm E - ORR as assessed by RECIST v1.1 by blinded independent central review

Gilead Sciences

Arcus Biosciences, Inc.

HLX10 + chemotherapy (carboplatin nab paclitaxel)

Placebo + chemotherapy (carboplatin nab paclitaxel), After 1st PD, the subject will be unblinded by the investigator and be continued with HLX10 monotherapy

HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.

HLX10

carboplatin and nab paclitaxel

Placebo

This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10 + chemotherapy vs chemotherapy in subjects with locally advanced or metastatic squamous NSCLC who have not previously received systemic treatment.

Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows:

Arm A (HLX10 arm): HLX10 + chemotherapy (carboplatin nab paclitaxel) Arm B (placebo arm): Placebo + chemotherapy (carboplatin nab paclitaxel) The three stratification factors for randomization include: PD-L1 expression level (Tumor Proportion Scores \[TPS\]≥50%, 50%\>TPS≥1%, TPS\<1%), Asian population (yes or no), NSCLC stage (stage IIIB/IIIC or stage IV), and carboplatin AUC (5 or 6).

A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy (Carboplatin-Nanoparticle Albumin Bound (Nab) Paclitaxel) in Patients With Stage IIIB/IIIC or IV NSCLC

A Randomized, Double-Blind, Multicenter, Phase III Clinical Study of HLX10 (Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection) + Chemotherapy (Carboplatin Nanoparticle Albumin Bound (Nab)-Paclitaxel) vs Chemotherapy (Carboplatin Nab-Paclitaxel) as First-Line Therapy for Locally Advanced or Metastatic Squamous Non Small Cell Lung Cancer (NSCLC)

Progression-free survival (PFS) (assessed by the independent radiology review committee \[IRRC\] based on Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1)

Shanghai Henlius Biotech

Immunomodulating Agents

Participants will receive zimberelimab as an intravenous (IV) infusion.

Participants will receive domvanalimab IV in combination with zimberelimab IV infusion.

Participants will receive oral etrumadenant in combination with domvanalimab IV and zimberelimab IV infusion

Etrumadenant is an A2aR and A2bR antagonist

Etrumadenant

This randomized phase 2 open-label study will evaluate the safety and efficacy of zimberelimab (AB122) monotherapy, domvanalimab (AB154) in combination with zimberelimab, and domvanalimab in combination with zimberelimab and etrumadenant (AB928) in front-line, PD-L1 positive, metastatic non-small cell lung cancer.

This is an open-label phase 2 study in participants with non-small cell lung cancer which will assess the safety, efficacy and tolerability of zimberelimab as monotherapy and in combination with other immunotherapeutics across multiple treatment arms.

Approximately 150 participants will be randomized to 1 of 3 treatment arms: 1) zimberelimab, 2) zimberelimab + domvanalimab (anti-TIGIT antibody), 3) zimberelimab + domvanalimab + etrumadenant (dual adenosine receptor antagonist). Participants that progress on the zimberelimab monotherapy arm may cross-over to receive the third arm combination of zimberelimab + domvanalimab + etrumadenant.

The primary objective of this clinical study is to evaluate the efficacy of each combination therapy by assessing: 1) objective response rate (ORR) of participants with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and 2) progression free survival (PFS).

Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer

A Phase 2 Study to Evaluate the Safety and Efficacy of AB122 Monotherapy, AB154 in Combination With AB122, and AB154 in Combination With AB122 and AB928 in Front-Line, Non-Small Cell Lung Cancer

The number and percentage of participants that experience TEAE

Serum concentration of zimberelimab as determined by validated assays

Serum concentration of domvanalimab as determined by validated assays

Serum concentration of etrumadenant as determined by validated assays

Percentage of participants who develop treatment-emergent anti-drug antibodies to zimberelimab

Percentage of participants who develop treatment-emergent anti-drug antibodies to domvanalimab

Necitumumab

Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.

Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.

Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle.

The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles. Necitumumab may continue until Progressive Disease (PD), toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.

Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles. After completion of chemotherapy, participants will be followed until radiographic documentation of PD.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy of paclitaxel and carboplatin is more effective to treat cancer than the standard chemotherapy of paclitaxel and carboplatin alone.

A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung Cancer

A Randomized, Multicenter, Open-Label, Phase 2 Study of Paclitaxel-Carboplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Paclitaxel-Carboplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

The denominator of ORR (Objective Response Rate) includes each participant enrolled who received any amount of study drug (necitumumab, gemcitabine, and/or cisplatin), and who had a complete radiographic assessment at baseline and at least one complete radiographic assessment post-baseline. The numerator includes those participants counted in the denominator with a confirmed best overall tumor response of partial or complete response (Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

OS defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS was censored at the last contact date (last contact for participants in post-discontinuation = last known alive date in mortality status).

Progression-Free Survival (PFS) is defined as the time from randomization until the first radiographically documented progressive disease (PD) or death from any cause. PD defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST version 1.1) as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last complete radiographic assessment.

Defined using the same denominator as defined in ORR. Among participants counted in the denominator, the numerator counts those with a confirmed best tumor response of SD, PR, or CR per RECIST 1.1. (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PR at least 30% decrease in the sum of diameter of target lesions; CR: disappearance of all target lesions).

CTS is defined as maximum percent change from baseline in the sum of target lesions.

Eli Lilly and Company

All participants who received at least 1 dose of study drug.

Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.

Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.

Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles.

Necitumumab +Paclitaxel+Carboplatin

Paclitaxel 200 mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.

Paclitaxel + Carboplatin

Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.

Paclitaxel 200 milligram per square meter (mg/m\^2) administered IV on Day 1 of every 3 week cycle.

Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.

Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Russia

United States

Poland

South Korea

Mexico

Germany

Region of Enrollment

Chief Medical Officer

Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.

Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.

Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle.

All randomized participants that received at least 1 dose of study drug, who had a complete radiographic assessment at baseline and at least 1 complete radiographic assessment post-baseline.

Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])

Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.

All randomized participants; (49 and 19 censored participants in Paclitaxel + Carboplatin + Necitumumab and Paclitaxel + Carboplatin Arms, respectively.

Overall Survival (OS)

Cycle 1, Day 1 (n=92)

Cycle 3, Day 1 (n=72)

Cycle 5, Day 1 (n=62)

All participants who received at least one dose of necitumumab and had evaluable PK data.

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab

Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.

Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.

Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.

Necitumumab + Paclitaxel+ Carboplatin

All participants who received any amount of necitumumab and had post baseline antibody data.

Percentage of Participants With Anti Necitumumab Antibodies

Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.

All randomized participants; with 15 and 7 censored participants in Paclitaxel +Carboplatin + Necitumumab and Paclitaxel +Carboplatin Arms, respectively.

Progression-Free Survival

All randomized participants who received at least 1 dose of study drug and who had a complete radiographic assessment.

Percentage of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])

Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.

Paclitaxel 200 mg per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.

Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.

All randomized participants who received at least 1 dose of study drug and who had a decrease from baseline in the sum of target lesions.

Percent Change in Tumor Size (CTS)

Cycle 1, Day 8 (n-85)

Cycle 2, Day 1 (n=79)

Cycle 3, Day 1 (n=76)

Cycle 4, Day 1 (n=70)

Cycle 6, Day 1 (n=59)

All participants who received at least one dose of study drug and had evaluable PK data.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study Comparing the Combination Domvanalimab and Zimberelimab With Pembrolizumab in Untreated Locally Advanced or Metastatic PD-L1-High Non-Small Cell Lung Cancer	NCT04736173	Non Small Cell ... Nonsquamous Non... Squamous Non Sm... Lung Cancer	Domvanalimab Zimberelimab Carboplatin Paclitaxel Pemetrexed Pembrolizumab	18 Years -	Arcus Biosciences, Inc.
A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy (Carboplatin-Nanoparticle Albumin Bound (Nab) Paclitaxel) in Patients With Stage IIIB/IIIC or IV NSCLC	NCT04033354	Squamous Non Sm...	HLX10 carboplatin and... Placebo	18 Years -	Shanghai Henlius Biotech
Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer	NCT04262856	Non Small Cell ... Nonsquamous Non... Squamous Non Sm... Lung Cancer	Domvanalimab Etrumadenant Zimberelimab	18 Years -	Arcus Biosciences, Inc.
A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung Cancer	NCT01769391	Squamous Non Sm...	Necitumumab Paclitaxel Carboplatin	18 Years -	Eli Lilly and Company

Spots Global Cancer Trial Database for squamous non small cell lung cancer