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

Micronutrients

Hematinics

Vitamins

Pembrolizumab

Carboplatin

Pemetrexed

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Vudalimab intravenous + carboplatin intravenous + pemetrexed intravenous

Vudalimab + Carboplatin + Pemetrexed

Pembrolizumab intravenous + carboplatin intravenous + pemetrexed intravenous

Pembrolizumab + Carboplatin + Pemetrexed

Michael Chiarella

Jolene Shorr

The purpose of this study is to identify the recommended dose of vudalimab to be used in combination with chemotherapy (Part 1) and to evaluate the efficacy and safety of vudalimab plus standard of care chemotherapy relative to pembrolizumab plus chemotherapy (Part 2) as first-line treatment in patients with nonsquamous non-small cell lung cancer (NSCLC).

This is a Phase 1b/2 study, multicenter, open-label, randomized study in patients with nonsquamous non-small cell lung cancer without prior treatment for metastatic disease. Part 1 is designed to identify the recommended Phase 2 dose (RP2D) of vudalimab, an anti-PD-1/CTLA-4 bispecific antibody, in combination with standard of care (SOC) chemotherapy. Part 2 will evaluate the efficacy and safety vudalimab, at the RP2D, plus SOC relative to pembrolizumab (anti-PD-1) plus SOC chemotherapy.

Study of Vudalimab or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced NSCLC

A Phase 1b/2, Open-label, Randomized Study of Vudalimab in Combination With Chemotherapy or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced Non-small Cell Lung Cancer

Incidence of treatment-emergent adverse events and treatment-related adverse events leading to discontinuation of treatment

Progressive disease per RECIST 1.1 or death, whichever comes first

Objective response rate as determined by investigator, duration of response (Part 1 and Part 2)

Examine ctDNA changes as a surrogate marker for disease burden (Part 1 and Part 2)

Xencor, Inc.

Amino Acids

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

Group of participants with non-small cell lung cancer (NSCLC) of nonsquamous histology who were assigned to Pemetrexed arm

Group of participants with NSCLC of nonsquamous histology who were assigned to Pemetrexed + Erlotinib arm

Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed arm

Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed + Erlotinib arm

500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity

150 mg given orally (po), daily (QD), starting on the first day of the first cycle

Erlotinib

500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity

150 mg given po, QD, starting on the first day of the first cycle

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)

This is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line setting (such as progression-free survival \[PFS\], disease control rate, best response rate, time to treatment failure \[TTTF\], overall survival \[OS\] and 1-year survival rates) compared to pemetrexed plus erlotinib combination.

Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 Study of Pemetrexed Versus Pemetrexed Plus Erlotinib in Second-Line Treatment in Patients With Nonsquamous NSCLC

PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria using computed tomography (CT) or magnetic resonance imaging (MRI) for objective determination of progressive disease (PD: ≤20% increase in sum of longest diameter of target lesion). For participants alive as of data cut-off date who did not have PD, PFS was censored at date of last CT/MRI. For participants who received subsequent systemic anticancer therapy (after study discontinuation) prior to PD or death, PFS censored at date of last CT/MRI prior to initiation of post discontinuation systemic anticancer therapy.

Per RECIST:

CR: Disappearance of all target lesions; PR: Either a) ≤30% decrease in sum of longest diameter (LD) of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) of ≥1 nontarget lesions. In either case, no new lesions may have appeared.

SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.

PD: ≤20% increase in sum of LD of target lesions. Disease Control Rate (%) = (SD+PR+CR)/number of participants in arm\*100.

CR: Disappearance of all tumor lesions; PR: Either a) at least a 30% decrease in sum of LD of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) ≥1 nontarget lesions. In either case, no new lesions may have appeared.

SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.

PD: ≤20% increase in the sum of LD of target lesions. Response Rate (%) = (CR+PR)/number of participants in arm\*100.

Defined as the time from randomization to death from any cause, first observation of PD, or study treatment discontinuation due to any reason other than "protocol complete" or "satisfactory response". For participants who discontinued due to "protocol complete" or "satisfactory response", or for participants not known to have discontinued as of the data cut-off date, TTTF was censored at the last contact date.

OS time is the duration from randomization to the date of death from any cause. For each participant who was not known to have died as of the data inclusion cut-off date, OS was censored at the date of last contact.

Overall Survival (OS) rate at 1 year from the date of randomization was determined using the distribution of OS times and was estimated using the Kaplan-Meier method.

Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.

Eli Lilly and Company

Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity

Pemetrexed (Nonsquamous and Squamous)

Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity

Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle

Pemetrexed + Erlotinib (Nonsquamous and Squamous)

Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity

Pemetrexed (Nonsquamous)

Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity

Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle

Pemetrexed + Erlotinib (Nonsquamous)

Pemetrexed (Squamous)

Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity

Erlotinib: 150 mg given po, QD, starting on the first day of the first cycle

Pemetrexed + Erlotinib (Squamous)

Total

Age Continuous

Sex: Female, Male

Caucasian

African

Hispanic

Native American

East Asian

West Asian

Race/Ethnicity, Customized

Austria

Germany

Spain

Hungary

Sweden

Region of Enrollment

Status 0

Status 1

Status 2

Unknown

Eastern Cooperative Oncology Group (ECOG) Performance Status classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).

0 - Fully Active

1. - Ambulatory, Restricted Strenuous Activity
2. - Ambulatory, No Work Activities
3. - Partially Confined to Bed, Limited Self Care
4. - Completely Disabled

Eastern Cooperative Oncology Group (ECOG) Performance Status

Histopathological

Cytological

Basis for Diagnosis

Adenocarcinoma of the lung

Mixed cell (squamous/adenocarcinoma)

Large cell lung carcinoma

Bronchioalveolar carcinoma

Squamous cell carcinoma of the lung

Initial Pathological Diagnosis

Stage I

Stage II

Stage IIIA

Stage IIIB

Stage IV

Disease Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body).

Stage 0 - the cancer has not spread beyond the inner lining of the lung Stage I - the cancer is small and hasn't spread to the lymph nodes Stage II - the cancer has spread to some lymph nodes near the original tumor Stage III - the cancer has spread to nearby tissue or spread to far away lymph nodes Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver

Stage of Disease at Study Entry

Never smoked

Ex-smoker

Current smoker

Smoking status

Up to 15 pack-years

More than 15 pack-years

Pack-year equals the number of cigarette packs smoked per day multiplied by the number of years the participant has smoked. For example, 1 pack-year is equal to smoking an average of 20 cigarettes per day (1 pack) for 1 year.

Pack-years, smokers only

Baseline Characteristics are presented by histology (nonsquamous/squamous) for each arm. Per the protocol amendment of August 2008, study entry criteria were changed to exclude participants with predominantly squamous cell histology.

Chief Medical Officer

Includes Nonsquamous population only.

In Pemetrexed arm, 13 (15.7%) participants censored overall: 12 (14.5%) because of receiving subsequent systemic anticancer therapy.

In Pemetrexed + Erlotinib arm, 16 (21.1%) participants censored overall: 9 (11.8%) because of receiving subsequent systemic anticancer therapy.

Progression Free Survival (PFS)

Percentage of Participants With Best Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Disease Control Rate)

Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Response Rate)

Time to Treatment Failure (TTTF)

Pemetrexed arm: 17 (20.5%) participants censored Pemetrexed + Erlotinib arm: 28 (36.8%) participants censored

Overall Survival (OS)

Includes nonsquamous population only.

On the Pemetrexed arm, 17 participants were censored overall and on the Pemetrexed + Erlotinib arm, 28 participants were censored overall.

Percentage of Participants Surviving at 1 Year

serious adverse events

other adverse events

All participants who received at least 1 dose of study drug were analyzed for safety. Nonsquamous and squamous populations are combined.

Number of Participants With Adverse Events (AEs)

Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression or unacceptable toxicity

Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity

Erlotinib: 150 mg given orally (po), daily (QD), starting on the first day of the first cycle

Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity

Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity

Erlotinib: 150 mg given po, QD, starting on the first day of the first cycle

Overall Study

Antibodies

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

INCMGA00012 with pemetrexed + cisplatin OR carboplatin followed by INCMGA00012 plus pemetrexed until progression.

Placebo with pemetrexed + cisplatin OR carboplatin followed by placebo plus pemetrexed until progression. Participants assigned to placebo + chemotherapy will have the option of receiving open-label monotherapy INCMGA00012 in a crossover period after documentation of progressive disease.

INCMGA00012 with carboplatin + paclitaxel OR nab-paclitaxel followed by INCMGA00012 until progression.

Placebo with carboplatin + paclitaxel OR nab-paclitaxel followed by placebo until progression. Participants assigned to placebo + chemotherapy will have the option of receiving open-label monotherapy INCMGA00012 in a crossover period after documentation of progressive disease.

INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.

Retifanlimab

Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.

Placebo

Pemetrexed administered intravenously every 3 weeks on Day 1 of each cycle.

Cisplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.

Carboplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.

Paclitaxel administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.

nab-Paclitaxel administered intravenously every 3 weeks on Days 1, 8, and 15 of each cycle for 4 cycles.

nab-Paclitaxel

Incyte Medical Monitor

The purpose of this study is to assess the efficacy and safety of platinum-based chemotherapy with or without INCMGA00012 in participants with metastatic squamous and nonsquamous non-small cell lung cancer (NSCLC).

Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer

A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non-Small Cell Lung Cancer (POD1UM-304)

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Defined as the time from randomization until death due to any cause.

Defined as the time from randomization until disease progression by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by blinded independent central review (BICR) or death due to any cause.

Defined as the proportion of participants who have a confirmed complete response or partial response per RECIST v1.1 based on BICR.

Defined as the time from the earliest date of documented response until earliest date of disease progression (per RECIST v1.1 based on BICR) or death from any cause, whichever comes first.

Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 90 days after last dose of study treatment.

Maximum observed plasma or serum concentration.

Area under the plasma or serum concentration curve.

Incyte Corporation

Panitumumab

Panitumumab 9 mg/kg BW will be administered IV every 3 weeks (q3w) for a maximum of four cycles.

In case of CR, PR or SD status at the end of the combination treatment, a panitumumab single drug treatment, consisting of 9 mg/kg BW administered every 3 weeks, will be performed until detection of disease progression.

Pemetrexed 500 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.

Cisplatin 75 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.

Wolfgang Schütte, MD

The purpose of this trial is to estimate the therapeutic efficacy of the experimental targeted regimen including the EGFR antibody panitumumab (in combination with pemetrexed and cisplatin) in relation to the standard combination in patients with a KRAS wild-type stage IIIB or IV primary nonsquamous non-small cell lung cancer. It is expected that the progression free survival rate at 6 months is improved by the targeted regimen.

Panitumumab Plus Pemetrexed and Cisplatin (PemCisP) Versus PemCis in the First-line Treatment of Patients With Non-small Cell Lung Cancer

CHAMP - An Open-label, Randomised, Multicentre, Phase II Clinical Study of Panitumumab Plus Pemetrexed and Cisplatin (PemCisP) Versus PemCis in the First-line Treatment of Patients With Stage IIIB or IV Primary Nonsquamous Non-small Cell Lung Cancer, With Particular Regard to the KRAS Status

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

WiSP Wissenschaftlicher Service Pharma GmbH

Mitogens

Necitumumab

500 milligram per square meter (mg/m2) administered Intravenously (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles

75 mg/m2 administered I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles

800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V.

The research study is testing the investigational drug necitumumab in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and pemetrexed will be more effective in improving participant disease than the standard chemotherapy combination alone.

Multinational, randomized, multicenter, open-label Phase 3 study of 633 participants with advanced, nonsquamous (Stage IV) NSCLC. Participants will be randomized on a 1:1 basis to receive first-line necitumumab plus chemotherapy consisting of pemetrexed and cisplatin in study Arm A, or first-line pemetrexed-cisplatin chemotherapy alone in Arm B.

Baseline radiographic assessment of disease will be performed within 21 days prior to randomization (first treatment will be administered within 7 days following randomization).

Participants will undergo radiographic assessment (computed tomography or magnetic resonance imaging) of disease status every 6 weeks (± 3 days), until there is radiographic documentation of progressive disease (PD). Chemotherapy will continue for a maximum of six cycles in each arm (Or until there is radiographic documentation of PD, toxicity requiring cessation, protocol noncompliance or withdrawal of consent); participants in Arm A only will continue to receive necitumumab until there is radiographic documentation of PD, toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.

After the end-of-study-visit (following PD), follow-up information regarding further anticancer treatment and survival will be collected every 2 months (± 7 days). For participants who discontinue study for reasons other than PD (eg, symptomatic deterioration), information on disease progression will also be collected until PD is documented. Follow-up will continue as long as the participant is alive, or until the end of the trial.

First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin

A Randomized, Multicenter, Open-Label Phase 3 Study of Pemetrexed-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Pemetrexed-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Nonsquamous 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 assigned data sharing agreement.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Vudalimab or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced NSCLC	NCT06173505	Nonsquamous Non...	Vudalimab + Car... Pembrolizumab +...	18 Years -	Xencor, Inc.
Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)	NCT00447057	Histological or...	Pemetrexed Erlotinib Pemetrexed Erlotinib	18 Years -	Eli Lilly and Company
Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer	NCT04205812	Metastatic Squa... Metastatic Nons...	Retifanlimab Placebo Pemetrexed Cisplatin Carboplatin Paclitaxel nab-Paclitaxel	18 Years -	Incyte Corporation
Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer	NCT04205812	Metastatic Squa... Metastatic Nons...	Retifanlimab Placebo Pemetrexed Cisplatin Carboplatin Paclitaxel nab-Paclitaxel	18 Years -	Incyte Corporation
Panitumumab Plus Pemetrexed and Cisplatin (PemCisP) Versus PemCis in the First-line Treatment of Patients With Non-small Cell Lung Cancer	NCT01088620	Carcinoma, Non-...	Panitumumab Pemetrexed Cisplatin	18 Years -	WiSP Wissenschaftlicher Service Pharma GmbH
First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin	NCT00982111	Non Small Cell ...	Pemetrexed Cisplatin Necitumumab	18 Years -	Eli Lilly and Company
A Study of Pemetrexed and Carboplatin/Cisplatin or Gemcitabine and Carboplatin/Cisplatin With or Without IMC-1121B in Participants Previously Untreated With Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC)	NCT01160744	Carcinoma, Non-...	IMC-1121B (ramu... Pemetrexed Carboplatin (AU... Cisplatin Gemcitabine Carboplatin (AU...	18 Years -	Eli Lilly and Company
A Study of Pemetrexed and Carboplatin/Cisplatin or Gemcitabine and Carboplatin/Cisplatin With or Without IMC-1121B in Participants Previously Untreated With Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC)	NCT01160744	Carcinoma, Non-...	IMC-1121B (ramu... Pemetrexed Carboplatin (AU... Cisplatin Gemcitabine Carboplatin (AU...	18 Years -	Eli Lilly and Company

Spots Global Cancer Trial Database for nonsquamous

Every month we try and update this database with for nonsquamous cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nonsquamous

Every month we try and update this database with for nonsquamous cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nonsquamous cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.