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NeoplasmsPhase 2NCT03739710

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

A Phase 2 study testing Docetaxel, Feladilimab and Ipilimumab in people with Neoplasms, run by GlaxoSmithKline at 57 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will compare the clinical activity of novel regimens (in combination or as single agents) to SoC in participants with relapsed/refractory advanced NSCLC. The study will be conducted in two parts. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
Docetaxel, Feladilimab and Ipilimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
175 participants
Where
57 sitesin 12 countries
Study dates
24 Jan 2019to 2 May 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 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
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  • 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:
  • Not a woman of childbearing potential (WOCBP) or ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
  • Life expectancy of at least 12 weeks.

Who cannot join

  • 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.
Show all 38Show fewer
  • 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.
  • Toxicity from previous anticancer treatment that includes:
  • Greater than or equal to (>=) Grade 3 toxicity considered related to prior immunotherapy and that led to treatment discontinuation.
  • History of myocarditis of any grade during a previous treatment with immunotherapy
  • Toxicity related to prior treatment that has not resolved to <= Grade 1 (except alopecia, hearing loss, endocrinopathy managed with replacement therapy, and peripheral neuropathy which must be <= Grade 2).
  • History (current and past) of idiopathic pulmonary fibrosis, pneumonitis (for past- pneumonitis exclusion only if steroids were required for treatment), interstitial lung disease, or organizing pneumonia.
  • Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions.
  • Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess.
  • History or evidence of cardiac abnormalities within the 6 months prior to enrollment which include
  • Serious, uncontrolled cardiac arrhythmia or clinically significant electrocardiogram abnormalities including second degree (Type II) or third degree atrioventricular block.
  • Cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting or bypass grafting.
  • Symptomatic pericarditis.
  • Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypo-albuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
  • Active infection requiring systemic therapy <=7 days prior to first dose of study treatment.
  • Participants with known human immunodeficiency virus infection.
  • Participants with history of severe hypersensitivity to mAb or hypersensitivity to any of the study treatment(s) or their excipients.
  • Participants requiring ongoing therapy with a medication that is a strong inhibitor or inducer of the cytochrome P 3A4 (CYP3A4) enzymes.
  • Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other condition that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator.
  • Pregnant or lactating female participants.
  • Participant who is currently participating in or has participated in a study of an investigational device within 4 weeks prior to the first dose of study treatment.
  • Participants with presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention.
  • Participants with positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
  • Participants with positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment.
  • Receipt of transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor, and recombinant erythropoietin) within 14 days before the first dose of study intervention.

Trial locations and contacts

57 sites in 12 countries.

57 sites in 12 countries

Spain9 sites

  • GSK Investigational Site

    Badajoz, 06080

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Madrid, 28027

  • GSK Investigational Site

    Madrid, 28033

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Santander, 39008

  • GSK Investigational Site

    Seville, 41009

Other trials in Spain

United States7 sites

  • GSK Investigational Site

    Chattanooga, Tennessee, 37404

  • GSK Investigational Site

    Dallas, Texas, 75230

  • GSK Investigational Site

    Los Angeles, California, 90025

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    Pinehurst, North Carolina, 28374

  • GSK Investigational Site

    St Louis, Missouri, 63110-1093

  • GSK Investigational Site

    The Bronx, New York, 10461-2375

Other trials in United States

Germany7 sites

  • GSK Investigational Site

    Berlin, 14165

  • GSK Investigational Site

    Gauting, 82131

  • GSK Investigational Site

    Großhansdorf, 22927

  • GSK Investigational Site

    Heidelberg, 69126

  • GSK Investigational Site

    Immenhausen, 34376

  • GSK Investigational Site

    Kassel, 34125

  • GSK Investigational Site

    Leipzig, 04357

Other trials in Germany

France6 sites

  • GSK Investigational Site

    Bordeaux, 33076

  • GSK Investigational Site

    Caen, 14033

  • GSK Investigational Site

    Paris, 75018

  • GSK Investigational Site

    Paris, 75248

  • GSK Investigational Site

    Saint-Herblain, 44093

  • GSK Investigational Site

    Villejuif, 94805

Other trials in France

Italy6 sites

  • GSK Investigational Site

    Meldola FC, 47014

  • GSK Investigational Site

    Milan, 20133

  • GSK Investigational Site

    Naples, 80131

  • GSK Investigational Site

    Orbassano to, 10043

  • GSK Investigational Site

    Ravenna, 48121

  • GSK Investigational Site

    Siena, 53100

Other trials in Italy

Romania5 sites

  • GSK Investigational Site

    Bucharest, 020142

  • GSK Investigational Site

    Craiova, 200347

  • GSK Investigational Site

    Floreşti, 407280

  • GSK Investigational Site

    Otopeni, 075100

  • GSK Investigational Site

    Timișoara, 300166

Other trials in Romania

South Korea4 sites

  • GSK Investigational Site

    Cheongju Chungcheongbuk-do, 28644

  • GSK Investigational Site

    Gyeonggi-do, 10408

  • GSK Investigational Site

    Seongnam-si Gyeonggi-do, 13620

  • GSK Investigational Site

    Seoul, 05505

Other trials in South Korea

Canada3 sites

  • GSK Investigational Site

    Brampton, Ontario, L6R 3J7

  • GSK Investigational Site

    Edmonton, Alberta, T6G 1Z2

  • GSK Investigational Site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Poland3 sites

  • GSK Investigational Site

    Lodz, 93-513

  • GSK Investigational Site

    Poznan, 60-569

  • GSK Investigational Site

    Warsaw, 02-781

Other trials in Poland

Russia3 sites

  • GSK Investigational Site

    Chelyabinsk, 454048

  • GSK Investigational Site

    Saint Petersburg, 194291

  • GSK Investigational Site

    Saint Petersburg, 197183

Other trials in Russia

Netherlands2 sites

  • GSK Investigational Site

    Amsterdam, 1081 HV

  • GSK Investigational Site

    Maastricht, 6229 HX

Other trials in Netherlands

Sweden2 sites

  • GSK Investigational Site

    Stockholm, SE-171 64

  • GSK Investigational Site

    Uppsala, SE- 75 185

Other trials in Sweden

About this study

Official title: A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants

This study will compare the clinical activity of novel regimens (in combination or as single agents) to SoC in participants with relapsed/refractory advanced NSCLC. The study will be conducted in two parts. Part 1 is an open-label, optional, non-randomized part based on safety and pharmacokinetics/pharmacodynamics (PK/PD) evaluation intended to generate additional data to qualify novel regimens for the randomized study. Part 2 is a randomized, Phase II open-label part comparing the efficacy and safety of these novel regimens with SoC. Drug name mentioned as GSK4428859A (belrestotug) and EOS884448 are interchangeable for the same compound and will be referred to as GSK4428859A/EOS884448/belrestotug.

Conditions
Neoplasms
Being tested
Docetaxel, Feladilimab, Ipilimumab, GSK4428859A, Dostarlimab
Keywords
Non-small cell lung cancer, Inducible t-cell co-stimulator (ICOS), Docetaxel, Standard of care, Immuno-oncology agents, TIGIT, Dostarlimab, Jemperli, GSK4428859A, belrestotug, EOS884448, GSK6097608, Anti-TIGIT, CD-96, Anti-CD-96
Medical subject headings
Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Docetaxel will be administered.

  • FeladilimabDrug

    Feladilimab will be administered.

  • IpilimumabDrug

    Ipilimumab will be administered.

  • GSK4428859ADrug

    Also called belrestotug, EOS884448

    GSK4428859A/EOS884448 will be administered.

  • DostarlimabDrug

    Dostarlimab will be administered.

  • GSK6097608Drug

    GSK6097608 will be administered.

Study groups in NCT03739710
Study groupRoleWhat they receive
Part 1: Participants receiving feladilimab and ipilimumabExperimentalNot described
Receives: Drug: Feladilimab; Drug: Ipilimumab
Part 1: Participants receiving dostarlimab plus GSK4428859A/EOS884448/belrestotugExperimentalNot described
Receives: Drug: GSK4428859A; Drug: Dostarlimab
Part 1: Participants receiving dostarlimab plus GSK4428859A/EOS884448/belrestotug plus GSK6097608ExperimentalNot described
Receives: Drug: GSK4428859A; Drug: Dostarlimab; Drug: GSK6097608
Part 2: Participants receiving SoC: docetaxelActive comparatorNot described
Receives: Drug: Docetaxel
Part 2: Participants receiving feladilimab and docetaxelExperimentalNot described
Receives: Drug: Docetaxel; Drug: Feladilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Randomized Across Sub-studies

    Number of Participants randomized across sub studies are presented.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2018
  2. Study start24 Jan 2019
  3. Primary completion2 May 2024
  4. Study completion2 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03739710
Sponsor's protocol ID
205801
Other IDs
2018-001316-29, 2018
Status last verified
Jun 2025
First submitted
9 Nov 2018
Last updated
15 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Feladilimab and Ipilimumab in people with Neoplasms, run by GlaxoSmithKline at 57 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in Spain, United States, Germany, France, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Randomized Across Sub-studies (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03739710.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.

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