Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 2

NCT06790303 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 205801-0022018-001316-29
• Study Type: interventional
• Target: 8
• Locations: 3 countries
• Sites: 3

Brief Summary

This study is a sub-study of the master protocol 205801 (NCT03739710). This sub study will assess the clinical activity of novel regimen (Feladilimab plus Ipilimumab) in participants with NSCLC.

Conditions

Neoplasms

Keywords

NSCLC; Feladilimab; Iplimumab

Outcome Measures

Primary Outcomes (9)

• Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).

  Up to 29 weeks

• Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)

  Criteria for dose-limiting toxicity (DLT) included hematologic indicators such as febrile neutropenia as defined by CTCAE v5; Grade 4 neutropenia of \>7 days in duration; Grade 4 anemia and Grade 3-4 thrombocytopenia with bleeding. Non-hematologic criteria, comprising Grade 4 toxicity; Grade 3 pneumonitis of any duration; Grade 3 toxicity that does not resolve to ≤Grade 1 or baseline within 3 days despite optimal supportive care; any Grade 2 ocular toxicity requiring systemic steroids, or any ≥ Grade 3 ocular toxicity Any other toxicity considered to be dose-limiting that occurs beyond four weeks was considered as DLT. Any other event which in the judgment of the investigator and GSK Medical Monitor is considered to be a DLT.

  Up to 21 days

• Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters

  Blood samples were collected for evaluation of hematology parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

  Baseline (Day 1) and up to 29 weeks

• Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters

  Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

  Baseline (Day 1) and up to 29 weeks

• Part 1: Number of Participants With Worst Case Change Post-baseline in Urinalysis Parameters

  Urine samples were collected for evaluation of urinalysis parameters using dipstick method. The dipstick test gave results in a semi-quantitative manner. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'Any increase', or 'no changes/decreased' values have been presented.

  Baseline (Day 1) and up to 29 weeks

• Part 1: Change From Baseline in Potential of Hydrogen (pH) of Urine

  Urine samples were collected from participants to assess urine pH levels. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Changes from baseline in urine pH were reported.

  Baseline (Day 1), week 4, week 7, week 10, week 13 and week 29 (Treatment Discontinuation)

• Part 1: Change From Baseline in Specific Gravity of Urine

  Urine samples were collected from participants to analyze urine specific gravity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Changes from baseline in specific gravity of urine were reported.

  Baseline (Day 1), week 4, week 7, week 10, week 13 and week 29 (Treatment Discontinuation)

• Part 1: Number of Participants With AE Leading to Dose Modifications

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. The number of participants who experienced AE leading to dose modifications were evaluated.

  Up to 29 weeks

• Part 2: Overall Survival

  OS is defined as the time from randomization until death due to any cause.

  Up to 29 weeks

Secondary Outcomes (17)

• Part 1: Overall Response Rate (ORR)

  Up to 29 weeks

• Part 1: Disease Control Rate (DCR)

  Up to 29 weeks

• Part 1: Maximum Concentration (Cmax) and Minimum Concentration (Cmin)

  Up to 29 weeks

• Part 2: Milestone Survival Rate at 12 and 18 Months

  At 12 and 18 months

• Part 2: Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) Based on RECIST 1.1

  Up to 29 weeks

Study Arms (1)

Feladilimab plus Ipilimumab

EXPERIMENTAL

Drug: Feladilimab; Drug: Ipilimumab

Interventions

Feladilimab DRUG

Feladilimab will be administered.

Feladilimab plus Ipilimumab

Ipilimumab DRUG

Ipilimumab will be administered

Feladilimab plus Ipilimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants capable of giving signed informed consent/assent.
• Male or female, aged 18 years or older at the time consent is obtained. Participants in Korea must be age 19 years or older at the time consent is obtained.
• Participants with histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous) and
• Participants capable of giving signed informed consent/assent.
• Male or female, aged 18 years or older at the time consent is obtained. Participants in Korea must be age 19 years or older at the time consent is obtained.
• Participants with histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous) and
• Documented disease progression based on radiographic imaging, during or after a maximum of 2 lines of systemic treatment for locally/regionally advanced recurrent, Stage IIIb/Stage IIIc/Stage IV or metastatic disease. Two components of treatment must have been received in the same line or as separate lines of therapy: i) No more than or less than 1 line of platinum-containing chemotherapy regimen, and ii) No more than or less than 1 line of Programmed cell death ligand 1 (PD\[L\]1) monoclonal antibody (mAb) containing regimen.
• Participants with known V-Raf Murine Sarcoma Viral Oncogene Homolog B (BRAF) molecular alterations must have had disease progression after receiving the locally available SoC treatment for the molecular alteration.
• Participants who received prior anti-PD(L)1 therapy must fulfill the following requirements: i) Have achieved a CR, PR or SD and subsequently had disease progression (per RECIST 1.1 criteria) either on or after completing PD(L)1 therapy ii) Have not progressed or recurred within the first 12 weeks of PD(L)1 therapy, either clinically or per RECIST 1.1 criteria
• Measurable disease, presenting with at least 1 measurable lesion per RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
• A tumor tissue sample obtained at any time from the initial diagnosis of NSCLC to time of study entry is mandatory. Although a fresh tumor tissue sample obtained during screening is preferred, archival tumor specimen is acceptable.
• Adequate organ function as defined in the protocol.
• A male participant must agree to use a highly effective contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions apply:

You may not qualify if:

• Participants who received prior treatment with the following therapies (calculation is based on date of last therapy to date of first dose of study treatment):
• Docetaxel at any time.
• Any of the investigational agents being tested in the current study.
• Systemic approved or investigational anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug is administered.
• Prior radiation therapy: permissible if at least one non-irradiated measurable lesion is available for assessment per RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented. A wash out of at least 2 weeks before start of study drug for radiation of any intended use is required.
• Received greater than (\>)2 prior lines of therapy for NSCLC, including participants with BRAF molecular alternations.
• Invasive malignancy or history of invasive malignancy other than disease under study within the last 2 years, except
• Any other invasive malignancy for which the participant was definitively treated, has been disease-free for at least 2 years and in the opinion of the principal investigator and GlaxoSmithKline Medical Monitor will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy, may be included in this clinical trial.
• Curatively treated non-melanoma skin cancer or successfully treated in situ carcinoma.
• Carcinomatous meningitis (regardless of clinical status) and uncontrolled or symptomatic Central nervous system (CNS) metastases.
• Major surgery less than or equal to (\<=) 28 days of first dose of study treatment.
• Autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years. Replacement therapies which include physiological doses of corticosteroids for treatment of endocrinopathies (for example, adrenal insufficiency) are not considered systemic treatments.
• Receiving systemic steroids (\>10 milligrams \[mg\]) oral prednisone or equivalent) or other immunosuppressive agents within 7 days prior to first dose of study treatment.
• Prior allogeneic/autologous bone marrow or solid organ transplantation.
• Receipt of any live vaccine within 30 days prior to first dose of study treatment.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Nashville, Tennessee, 37203, United States

Location

GSK Investigational Site

Brampton, Ontario, L6R3J7, Canada

Location

GSK Investigational Site

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Ipilimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Click here to enter text.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 24, 2025
• Study Start: March 4, 2021
• Primary Completion: September 23, 2021
• Study Completion: September 23, 2021
• Last Updated: June 4, 2025
• Results First Posted: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

US (1); CA (1); FR (1)