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Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )

ConditionsPancreatic CancerPancreatic Cancer MetastaticPDACPDAC - Pancreatic Ductal AdenocarcinomaPancreatic Ductal Adenocarcinoma (PDAC)Pancreatic Adenocarcinoma MetastaticPancreatic AdenocarcinomaPancreatic Adenosquamous Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRevolution Medicines, Inc.

About this trial

The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to placebo in combination with chemotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 18 years old and has provided informed consent.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Histologically or cytologically confirmed pancreatic adenocarcinoma.

Diagnosis of metastatic disease ≤ 6 weeks prior to screening.

Disqualifiers

Prior treatment with systemic anticancer therapy in unresectable locally advanced or metastatic setting.

Prior systemic RAS-targeted therapy any time prior to randomization.

Presence of other known driver mutations with approved targeted therapies

Active or known history of untreated central nervous system metastatic disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zoldonrasib

    Drug

    oral tablets

  • Placebo

    Drug

    oral tablets

  • Oxaliplatin

    Drug

    IV infusion

  • Leucovorin (Calcium Folinate)

    Drug

    IV infusion

  • 5-Fluorouracil

    Drug

    IV infusion

  • Irinotecan

    Drug

    IV infusion

  • Gemcitabine (GEM)

    Drug

    IV infusion

  • Nab-paclitaxel

    Drug

    IV infusion

Treatment groups

670 Participants
are divided into 2 treatment groups
Group A: Arm A: zoldonrasib + chemotherapyExperimental treatment 7 interventions
Group B: Arm B: placebo + chemotherapyPlacebo comparator 7 interventions

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per response evaluation criteria in solid tumors (RECIST) v1.1 by Investigator.

Time frame
Up to approximately 4 years
2

Overall survival (OS)

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

Time frame
Up to approximately 4 years

Secondary outcomes

1

PFS per blinded independent central review (BICR)

PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed RECIST v1.1 by BICR.

Time frame
Up to approximately 4 years
2

Objective response rate (ORR)

Objective response is defined as partial response (PR) or complete response (CR) as assessed per RECIST v1.1 by Investigator and BICR.

Time frame
Up to approximately 4 years
3

Duration of response (DOR)

DOR is defined as time from first evidence of objective response (PR or CR) to disease progression or death due to any cause, whichever occurs first, as assessed by the investigator and BICR.

Time frame
Up to approximately 4 years
4

Incidence of adverse events (AEs)

Percentage of patients with AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5

Time frame
Up to approximately 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Revolution Medicines, Inc.

Lead sponsor

Source ClinicalTrials.gov
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