Ris-Rez (Ph 3) for Neoplasms, Lung | GSK plc | BiopharmaWatch

Recently added Catalysts

Ris-Rez

Phase 3

Neoplasms, Lung | Monoclonal antibody | Oncology |GSK plc|Last Updated: Jul 15, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLEDDMC

Total Trials1

Total Enrollment420

FDA Designations

No designations recorded

Clinical trial landscape

Ris-Rez · 4 trials · 4 indications

Phase 3 1Phase 1 3

Indication

NCT07099898A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)Neoplasms, Lung

RECRUITING420 Analytics

PHASE3RECRUITING

A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)

Neoplasms, Lung

Unlock trial analytics

Study Endpoints

Primary Endpoints

Overall Survival (OS)

Up to approximately 113 weeks

OS is defined as the time from the date of randomization to the date of death by any cause

Confirmed Objective Response Rate (cORR)

Up to approximately 143 weeks

cORR is defined as the proportion of participants who have confirmed Complete Response (CR) or Partial Response (PR), assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1

Number of participants with Adverse events (AEs), Serious Adverse Events (SAEs) and Adverse events of special interest (AESIs) by severity

Up to approximately 143 weeks

Number of participants with AEs leading to dose modifications or study intervention discontinuation

Up to approximately 130 weeks

Number of participants with changes in safety parameters

Up to approximately 143 weeks

Number of participants will be assessed

Number of participants with Dose Limiting Toxicities (DLT)

Up to 21 days

Number of participants with a change from baseline in vital signs

Baseline (Day -1) and up to approximately 143 weeks

Number of participants will be assessed

Number of participants with a change from baseline in body weight

Baseline (Day -1) and up to approximately 143 weeks

Number of participants will be assessed

Number of participants with a change from baseline in laboratory parameters (hematology, clinical chemistry and urinalysis)

Baseline (Day -1) and up to approximately 143 weeks

Number of participants will be assessed

Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG) and Echocardiogram (ECHO)

Baseline (Day -1) and up to approximately 143 weeks

Number of participants will be assessed

Number of participants with a change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status

Baseline (Day -1) and up to approximately 143 weeks

Number of participants will be assessed

Cohort 1: Progression free survival rate at Week18 (PFS18)

At Week 18

PFS is defined as the time from the date of randomization until the date of documented disease progression or death due to any cause, whichever occurs first, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

Cohort 1 & 2: Confirmed Objective Response Rate (ORR)

Up to approximately 98 weeks

Confirmed ORR is defined as the proportion of participants who have achieved a confirmed Complete Response (CR) or Partial Response PR as assessed by investigator, according to RECIST 1.1

Phase 1a: Number of participants with Adverse Events (AEs)

Up to approximately 28 months

Phase 1a: Number of participants with Dose Limiting Toxicities (DLTs)

Up to 21 days

Phase 1a: Number of participants with AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) by severity

Up to approximately 30 months

Phase 1a: Number of participants with AEs leading to dose modifications

Up to approximately 28 months

Phase 1a: Number of participants with changes in vital signs, body weight, laboratory tests, electrocardiogram (ECG) and Eastern Cooperative Oncology Group (ECOG) performance status

Up to approximately 28 months

Phase 1b: Confirmed Objective Response Rate (cORR)

Up to approximately 27 months

cORR is defined as the proportion of participants who have confirmed Complete response (CR) or Partial response (PR), assessed by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) criteria or other imaging criteria for defined tumor types.

Secondary Endpoints

Objective Response Rate (ORR)

Up to approximately 139 weeks

Duration of Response (DoR)

Up to approximately 139 weeks

Progression-free survival (PFS)

Up to approximately 139 weeks

Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED

MaskingNONE

ModelPARALLEL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
Ris-Rez	EXPERIMENTAL	-
Topotecan	ACTIVE_COMPARATOR	-
Ris-Rez + Ivonescimab	EXPERIMENTAL	-
Cohort 1A (Ris-Rez)	EXPERIMENTAL	-
Cohort 1B [Ris-Rez + Granulocyte-Colony Stimulating Factor (G-CSF)]	EXPERIMENTAL	-
Cohort 2 (Ris-Rez)	EXPERIMENTAL	-
Phase 1a- Dose escalation- Monotherapy	EXPERIMENTAL	-
Phase 1a- Dose escalation- Combination therapy	EXPERIMENTAL	-
Phase 1b- Dose optimisation- Monotherapy	EXPERIMENTAL	-
Phase 1b- Dose optimisation- Combination therapy	EXPERIMENTAL	-
Phase 1b- Dose expansion- Monotherapy	EXPERIMENTAL	-
Phase 1b- Dose expansion- Combination therapy	EXPERIMENTAL	-

Interventions

Name	Type	Description
Ris-Rez	BIOLOGICAL	Ris-Rez will be administered
Topotecan	DRUG	Topotecan will be administered
Ivonescimab	BIOLOGICAL	Ivonescimab will be administered
G-CSF	BIOLOGICAL	G-CSF will be administered
Cisplatin	DRUG	Cisplatin will be administered
Carboplatin	DRUG	Carboplatin will be administered
Atezolizumab	BIOLOGICAL	Atezolizumab will be administered
Pembrolizumab	BIOLOGICAL	Pembrolizumab will be administered
Durvalumab	BIOLOGICAL	Durvalumab will be administered
Cetuximab	BIOLOGICAL	Cetuximab will be administered
Bevacizumab	BIOLOGICAL	Bevacizumab will be administered
Tarlatamab	BIOLOGICAL	Tarlatamab will be administered
Dostarlimab	BIOLOGICAL	Dostarlimab will be administered

Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A

SexALL

Healthy VolunteersNo

Study Sites120

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Adults \>18 or the minimum legal adult age at the time the informed consent form is signed * Has histologically or cytologically confirmed extensive-stage small cell lung cancer...

Countries:ArgentinaAustraliaBrazilBulgariaCanadaFinlandFranceGermanyGreeceHungaryIrelandIsraelItalyJapanMexicoPolandPortugalRomaniaSouth KoreaSpainSwedenSwitzerlandTurkey (Türkiye)United KingdomUnited StatesHong KongPanamaTaiwan

Unlock Eligibility Criteria

Competitive Landscape -Myeloproliferative Neoplasms 52 trials (matched to "Neoplasms, Lung")

Company	Ticker	Trials	Lead Phase	Drugs
Bristol-Myers Squibb Company	BMY	5	PHASE3	ACE-536
AbbVie, Inc.	ABBV	4	PHASE3	Navitoclax, Ruxolitinib
Novartis AG Sponsored ADR	NVS	3	PHASE3	Pelabresib, Ruxolitinib
Karyopharm Therapeutics, Inc.	KPTI	4	PHASE3	Selinexor, Ruxolitinib
Geron Corporation	GERN	2	PHASE3	Imetelstat
Merck & Co., Inc.	MRK	1	PHASE3	Bomedemstat
Incyte Corporation	INCY	10	PHASE2	Ruxolitinib
GSK plc Sponsored ADR	GSK	2	PHASE2	MMB
Takeda Pharmaceutical Co. Ltd. Sponsored ADR	TAK	1	PHASE2	Elritercept, Ruxolitinib
Eli Lilly and Company	LLY	1	PHASE1	LY3410738, Venetoclax, Azacitidine
Disc Medicine, Inc.	IRON	1	PHASE1	DISC-0974
Galecto, Inc.	GLTO	1	PHASE2	GB2064
Prelude Therapeutics, Inc.	PRLD	1	PHASE1	PRT12396
United Therapeutics Corporation	UTHR	1	PHASE2	bomedemstat

Unlock Competitive Intelligence

Recent Changes (Last 90 Days)

LOWJul 15, 2026NCT07602777Status: NOT_YET_RECRUITING → RECRUITING

LOWJul 15, 2026NCT07602777Status: NOT_YET_RECRUITING → RECRUITING

LOWMay 28, 2026NCT07099898lastUpdatePostDate: changed

LOWMay 28, 2026NCT07099898lastUpdatePostDate: changed

MEDIUMMay 26, 2026NCT07099898primaryCompletionDate: changed

MEDIUMMay 26, 2026NCT06551142Enrollment: 590 → 845

LOWMay 24, 2026NCT07099898studyFirstPostDate: changed

LOWMay 24, 2026NCT06551142studyFirstPostDate: changed