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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT03739710

Studienbeginn:
Januar 2019

Letztes Update:
29.06.2023

Wirkstoff:
Docetaxel, Ipilimumab, Dostarlimab, feladilimab, GSK6097608, GSK4428859A

Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
GlaxoSmithKline

Collaborator:
iTeos Belgium SA

Studienleiter

GSK Clinical Trials
Study Director
GlaxoSmithKline

Kontakt

EU GSK Clinical Trials Call Center
Kontakt:
Phone: +44 (0) 20 89904466
E-Mail: GSKClinicalSupportHD@gsk.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 58)

GSK Investigational Site
69126 Heidelberg
(Baden-Württemberg)
GermanyAbgeschlossen» Google-Maps
GSK Investigational Site
82131 Gauting
(Bayern)
GermanyAbgeschlossen» Google-Maps
GSK Investigational Site
34376 Immenhausen
(Hessen)
GermanyAbgeschlossen» Google-Maps
GSK Investigational Site
34125 Kassel
(Hessen)
GermanyAbgeschlossen» Google-Maps
GSK Investigational Site
04357 Leipzig
(Sachsen)
GermanyAbgeschlossen» Google-Maps
GSK Investigational Site
22927 Grosshansdorf
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
14165 Berlin
(Berlin)
GermanyAbgeschlossen» Google-Maps
GSK Investigational Site
90025 Los Angeles
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
63110-1093 Saint Louis
United StatesAbgeschlossen» Google-Maps
GSK Investigational Site
10461-2375 Bronx
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
10467 Bronx
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
28374 Pinehurst
United StatesAbgeschlossen» Google-Maps
GSK Investigational Site
37404 Chattanooga
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
37203 Nashville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
75230 Dallas
United StatesAbgeschlossen» Google-Maps
GSK Investigational Site
T6G 1Z2 Edmonton
CanadaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
L6R 3J7 Brampton
CanadaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
M5G 2M9 Toronto
CanadaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
33076 Bordeaux Cedex
FranceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
14033 Caen Cedex 9
FranceAbgeschlossen» Google-Maps
GSK Investigational Site
44093 Nantes cedex 1
FranceAbgeschlossen» Google-Maps
GSK Investigational Site
75248 Paris Cedex 05
FranceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
75018 Paris
FranceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
94805 Villejuif Cedex
FranceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
47014 Meldola (FC)
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
48121 Ravenna
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
20133 Milano
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
10043 Orbassano (TO)
ItalyAbgeschlossen» Google-Maps
GSK Investigational Site
53100 Siena
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
28644 Cheongju-si, Chungcheongbuk-do
Korea, Republic ofAbgeschlossen» Google-Maps
GSK Investigational Site
10408 Gyeonggi-do
Korea, Republic ofAbgeschlossen» Google-Maps
GSK Investigational Site
13620 Seongnam
Korea, Republic ofAbgeschlossen» Google-Maps
GSK Investigational Site
05505 Seoul
Korea, Republic ofAbgeschlossen» Google-Maps
GSK Investigational Site
1081 HV Amsterdam
NetherlandsAbgeschlossen» Google-Maps
GSK Investigational Site
6229 HX Maastricht
NetherlandsAbgeschlossen» Google-Maps
GSK Investigational Site
020142 Bucharest
RomaniaAbgeschlossen» Google-Maps
GSK Investigational Site
300166 Timisoara
RomaniaAbgeschlossen» Google-Maps
GSK Investigational Site
454048 Chelyabinsk
Russian FederationAbgeschlossen» Google-Maps
GSK Investigational Site
194291 Saint-Petersburg
Russian FederationAbgeschlossen» Google-Maps
GSK Investigational Site
197183 Saint-Petersburg
Russian FederationAbgeschlossen» Google-Maps
GSK Investigational Site
08035 Barcelona
SpainRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
28034 Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
29010 Málaga
SpainRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
SE- 75 185 Uppsala
SwedenAbgeschlossen» Google-Maps
Alle anzeigen

Studien-Informationen

Brief 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. 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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- 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

a) 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.

b) Participants with known BRAF molecular alterations must have had disease

progression after receiving the locally available SoC treatment for the molecular

alteration.

c) 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:

i) 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.

Exclusion Criteria:

- 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):

1. Docetaxel at any time.

2. Any of the investigational agents being tested in the current study.

3. 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.

4. 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.

- Toxicity from previous anticancer treatment that includes:

1. Greater than or equal to (>=) Grade 3 toxicity considered related to prior

immunotherapy and that led to treatment discontinuation.

2. History of myocarditis of any grade during a previous treatment with

immunotherapy

3. 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

1. Serious, uncontrolled cardiac arrhythmia or clinically significant

electrocardiogram abnormalities including second degree (Type II) or third degree

atrioventricular block.

2. Cardiomyopathy, myocardial infarction, acute coronary syndromes (including

unstable angina pectoris), coronary angioplasty, stenting or bypass grafting.

3. 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.

Studien-Rationale

Primary outcome:

1. Part 1: Number of participants with any adverse events (AEs) and serious adverse events (SAEs) (Time Frame - Up to 2 years)

2. Part 1: Number of participants with dose limiting toxicity (DLT) (Time Frame - Up to 2 years)

3. Part 1: Number of participants with clinically significant changes in vital signs, physical examination and laboratory parameters (Time Frame - Up to 2 years)

4. Part 1: Number of participants requiring dose modifications (Time Frame - Up to 2 years)

5. Part 2: Overall survival (Time Frame - Up to 3 years):
Overall survival will be calculated as time from randomization to death.

Secondary outcome:

1. Part 1: Objective response rate (Time Frame - Up to 2 years):
Objective response rate will be calculated as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. It is defined as the percentage of participants with a best overall confirmed complete response (CR) or partial response (PR) at any time as per disease-specific criteria.

2. Part 1: Disease control rate (DCR) (Time Frame - Up to 2 years):
DCR is defined as the percentage of participants with a best overall confirmed CR, PR or stable disease (SD) at any time as per disease-specific criteria.

3. Part 1: Maximum observed concentration (Cmax) and Minimum observed concentration (Cmin) of feladilimab (Time Frame - Up to 2 years)

4. Part 1: Cmax and Cmin of ipilimumab (Time Frame - Up to 2 years)

5. Part 1: Cmax and Cmin of GSK4428859A/EOS884448/belrestotug (Time Frame - Up to 2 years)

6. Part 1: Cmax and Cmin of dostarlimab (Time Frame - Up to 2 years)

7. Part 1: Cmax and Cmin of GSK6097608 (Time Frame - Up to 2 years)

8. Part 2: Survival rate at 12 and 18 months (Time Frame - At 12 and 18 months):
Milestone survival rate of participants treated with experimental regimens versus SoC therapy.

9. Part 2: Number of participants with CR, Partial response (PR), Stable disease (SD) and Progressive disease (PD) (Time Frame - Up to 2 years):
CR, PR, SD and PD will be evaluated as per RECIST version 1.1 criteria.

10. Part 2: Progression-free survival (PFS) (Time Frame - Up to 2 years):
PFS is defined as time from the date of randomization to the date of disease progression or death whichever occurs earlier.

11. Part 2: Objective response rate (ORR) (Time Frame - Up to 2 years):
ORR is defined as the percentage of participants with a confirmed CR or PR at any time per RECIST version 1.1 criteria.

12. Part 2: Duration of response (DOR) (Time Frame - Up to 2 years):
DOR is defined as the first documented evidence of CR or PR until disease progression or death, per RECIST 1.1 criteria.

13. Part 2: DCR (Time Frame - Up to 2 years):
DCR is defined as the percentage of participants with a best overall confirmed CR, PR or SD at any time as per disease-specific criteria.

14. Part 2: Number of participants with immune-based (i) iCR, iPR, unconfirmed progressive disease (iUPD), confirmed progressive disease (iCPD), and iSD (Time Frame - Up to 2 years):
Number of participants with iCR, iPR, iUPD, iCPD and iSD per modified RECIST 1.1 for immune-based therapeutics (iRECIST) criteria.

15. Part 2: Progression-free survival (iPFS) (Time Frame - Up to 2 years):
iPFS is defined as time from the date of randomization to the date of disease progression or death, whichever occurs earlier, per iRECIST criteria.

16. Part 2: Objective response rate (iORR) (Time Frame - Up to 2 years):
iORR is defined as the percentage of participants with a confirmed CR or PR at any time per iRECIST criteria.

17. Part 2: Duration of response (iDOR) (Time Frame - Up to 2 years):
iDOR is defined as the time from first documented evidence of CR or PR until disease progression or death, per iRECIST criteria.

18. Part 2: Number of participants with AEs, adverse events of special interest (AESI), SAEs and AE/SAEs leading to dose modifications/delays/withdrawals (Time Frame - Up to 2 years)

19. Part 2: Number of participants with clinically significant changes in vital signs, physical examination and laboratory parameters (Time Frame - Up to 2 years)

20. Part 2: Cmax and Cmin for SoC (docetaxel) (Time Frame - Up to 2 years)

21. Part 2: Cmax and Cmin for feladilimab (Time Frame - Up to 2 years)

22. Part 2: Number of participants with positive anti-drug antibodies (ADA) against docetaxel (Time Frame - Up to 2 years)

23. Part 2: Number of participants with positive ADA against feladilimab (Time Frame - Up to 2.5 years)

Studien-Arme

  • Experimental: Part 1: Participants receiving feladilimab and ipilimumab
  • Experimental: Part 1: Participants receiving dostarlimab plus GSK4428859A/EOS884448/belrestotug
  • Experimental: Part 1: Participants receiving dostarlimab plus GSK4428859A/EOS884448/belrestotug plus GSK6097608
  • Active Comparator: Part 2: Participants receiving SoC: docetaxel
  • Experimental: Part 2: Participants receiving feladilimab and docetaxel

Geprüfte Regime

  • Docetaxel:
    Docetaxel will be administered.
  • Feladilimab:
    Feladilimab will be administered.
  • Ipilimumab:
    Ipilimumab will be administered.
  • GSK4428859A (belrestotug / EOS884448 / ):
    GSK4428859A/EOS884448 will be administered.
  • Dostarlimab:
    Dostarlimab will be administered.
  • GSK6097608:
    GSK6097608 will be administered.

Quelle: ClinicalTrials.gov


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