Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Micronutrients

Hematinics

Vitamins

Carboplatin

Dexamethasone

Bevacizumab

Pemetrexed

Pembrolizumab

Cisplatin

Dexamethasone acetate

Folic Acid

Vitamin B Complex

Vitamin B 12

Hydroxocobalamin

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Trace Elements

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid Antagonists

Folinic Acid

Methylcobalamin

Folate

Vitamin B9

Vitamin B12

Cobalamin

Cyanocobalamin

Participants receive pembrolizumab 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4-6 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression.

Pembrolizumab was given as 200 milligrams (mg) via intravenous (IV) infusion over 30 minutes on Day 1 of each 21-day cycle.

Bevacizumab was given as 15 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle.

Pemetrexed was given as 500 mg/m\^2 via intravenous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle for 4-6 cycles.

Cisplatin was given as 75 mg/m\^2 via intravenous (IV) infusion (administered approximately 30 minutes after pemetrexed infusion) on Day 1 of each 21-day cycle for 4-6 cycles.

Carboplatin was given as Aare Under the Curve (AUC) 5 (5 mg/mL/min; over 15-60 min) via intravenous (IV) infusion (administered immediately after pemetrexed infusion) on Day 1 of each 21-day cycle for 4-6 cycles.

Orally; at least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and folic acid dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed.

Folic acid 350-1000 μg

Intramuscular injection in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be given on the same day as pemetrexed administration.

Vitamin B12 1000 μg

For prophylaxis; orally twice per day (or equivalent). Taken the day before, the day of, and the day after pemetrexed administration.

Dexamethasone 4 mg

Baohui Han, MD,PhD

Baohui Han, MD, PhD

This study is designed to evaluate the efficacy and safety of Pembrolizumab in combination with Bevacizumab and chemotherapy in advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutation.

Pembrolizumab Plus Bevacizumab and Chemotherapy for Non-Squamous NSCLC Patients

Pembrolizumab Plus Bevacizumab and Chemotherapy as First-Line Treatment for Advanced or Metastatic Non-Squamous NSCLC Patients With EGFR Exon 20 Insertion Mutation: An Open-Label, Single-Arm, Phase II Trial

ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1).

PFS is defined as the time from the first dose of study treatment to the first documented progressive disease (PD) per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on blinded independent central review (BICR), or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of ≥1 new lesion was also considered PD.

OS was defined as the time from the first dose of study treatment to death due to any cause.

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from the first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR with confirmation. The DOR per RECIST 1.1 for all participants who experienced a confirmed CR or PR is presented.

An AE was defined as any untoward medical occurrence in a participant-administered study treatment that did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE is presented.

The number of participants who discontinued any randomized study drug due to an AE is presented.

Spots Global Cancer Trial Database for Pembrolizumab Plus Bevacizumab and Chemotherapy for Non-Squamous NSCLC Patients

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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