Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Death

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

Micronutrients

Hematinics

Vitamins

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Antibodies

Pemetrexed

Cisplatin

Cemiplimab

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Antineoplastic Agents, Immunological

Folinic Acid

Folate

Vitamin B9

Randomized 1:1:1 fianlimab (higher dose) + cemiplimab + platinum-doublet chemotherapy

Randomized 1:1:1 fianlimab (lower dose) + cemiplimab + platinum-doublet chemotherapy

Randomized 1:1:1 cemiplimab + platinum-doublet chemotherapy + placebo

Randomized 1:1 fianlimab (chosen dose) + cemiplimab + platinum-doublet chemotherapy

Randomized 1:1 cemiplimab + platinum-doublet chemotherapy + placebo

Administered intravenously (IV) every 3 weeks (Q3W)

fianlimab

cemiplimab

Placebo

Clinical Trials Administrator

Abhinav Chandra, MD

Arati Chand

Timothy Byun, MD

Luke Dreisbach

Emad Ibrahim, MD

Jeremy Chuang

Gopal Kunta, MD

Niramol Savaraj, MD

Santosh Nair

Karen Russell, MD

Bruce Bank

Victor Lin, MD

John Hrom

Arturo Loaiza-Bonilla, MD

Atul Kumar, MD

Thomas Marron, MD

James D'Olimpio

Gabrail Nashat, MD

Jason Porter, MD

David Chism

Neil Faulkner, MD

Richard Hall

William Irvin

John Park

Daniel Paul Brungs

Wasek Faisal

Say Ng

Melissa Moore

Kynan Feeney

Sara Taylor

Tamta Makharadze

Ekaterine Arkania

Davit Giorgadze

Mamia Khutashvilli

Nia Shavdia

Mariam Zhvania

Tamar Melkadze

Miranda Gogishvilli

Vladimer Kuchava

Nana Chikhladze

Jair Bar, MD

Elizabeth Dudnik, MD

Ki Hyeong Lee

Joo-Hang Kim

Hyun Woo Lee

Eun-Kee Song

Sang-We Kim

Hyewon Ryu

Hee Kyung Ahn

Jeong Seon Ryu

Sung Yong Lee

Young Joo Min

Chen Sen Lim

SoonHin How, MD

Rakesh Raman

Pei Jye Voon, MD

Suhana Yusak

Ai Lian Tan, MD

Clinical Trial Management

This study is researching an investigational drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and chemotherapy, individually called a "study drug" or collectively called "study drugs". 'Investigational' means that the study drug is not approved for use outside of this study by any Health Authority. Examples of chemotherapy drugs include the following: Paclitaxel plus carboplatin, and Pemetrexed plus cisplatin. The study is being conducted in patients who have advanced non-small cell lung cancer (NSCLC).

The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is for treating advanced NSCLC, in comparison with cemiplimab and chemotherapy.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drugs
* How much of each study drug is in your blood at different times
* Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)
* How administering the study drugs might improve your quality of life

A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer

A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody), Cemiplimab (Anti-PD-1 Antibody), and Chemotherapy Versus Cemiplimab and Chemotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Irrespective of PD-L1 Expression Levels

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Phase 2 ORR is defined as proportion of patients with a best overall response of confirmed complete response (CR) or partial response (PR).

Phase 3 Defined as the time from randomization to the date of death due to any cause

Phase 2 \& Phase 3 A TEAE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment

Phase 2 \& Phase 3

Any untoward medical occurrence that at any dose:

* Results in death - includes all deaths, even those that appear to be completely unrelated to study drug (eg, a car accident in which a patient is a passenger)
* Is life-threatening
* Requires in-patient hospitalization or prolongation of existing hospitalization • Results in persistent or significant disability/incapacity
* Is a congenital anomaly/birth defect
* Is an important medical event

Phase 2 \& Phase 3 Serious or non-serious; is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the sponsor can be appropriate. Such an event might warrant further investigation in order to characterize and understand it.

Phase 2 \& Phase 3 Immune-mediated AEs are thought to be caused by unrestrained cellular immune responses directed at normal host tissues. An imAE can occur shortly after the first dose or several months after the last dose of treatment. Early detection and management reduces the risk of severe drug induced toxicity

Phase 2 \& Phase 3

≥ grade 3 per National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI-CTCAE v5.0\]

Phase 2 and Phase 3 DCR is defined as CR + PR + stable disease (SD)

Phase 2 and Phase 3 TTR is defined as the time from randomization to the date of the first response of CR or PR (whichever is first recorded) for patients with confirmed CR or PR.

Phase 2 and Phase 3 TTR is defined as the time from randomization to the date of the first response of CR or PR (whichever is first recorded) for patients with confirmed CR or PR

Phase 2 and Phase 3 DOR is defined as the time from first response of CR or PR to first radiographic progression or death due to any cause for patients with confirmed CR or PR

Phase 2 and Phase 3 PFS is defined as the time from randomization to the date of the first radiographic progression or death due to any cause, whichever occurred earlier

Phase 2 Defined as the time from randomization to the date of death due to any cause

Phase 2 \& Phase 3 EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a GHS/QoL scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.

Phase 2 \& Phase 3 EORTC QLQ-LC 13 is a lung cancer specific module developed to assess lung cancer-associated symptoms and treatment-related side effects among lung cancer patients

Phase 2 \& Phase 3 The EQ-5D-5L VAS records the respondent's self-rated health on a 10 centimeter (cm) vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine".

Phase 2 \& Phase 3 PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trials using a PRO-CTCAE score. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE.

Regeneron Pharmaceuticals

Spots Global Cancer Trial Database for african descent