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New targeted pill shows promise for tough lung cancer

NCT ID NCT06343402

Disease control Sponsor: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This early-stage trial tests an experimental drug called BBO-8520 in 350 people with advanced non-small cell lung cancer that has a specific genetic change (KRAS G12C). The drug is taken as a pill and aims to block cancer growth. The study will check for safety, side effects, and whether the tumor shrinks. Some participants may also receive the drug with other treatments like pembrolizumab.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BBO-8520 (an experimental drug taken orally that targets the KRAS G12C mutation)
What this could lead to
If successful, this could lead to a new treatment option for people with a specific type of advanced lung cancer that has limited targeted therapies.
What could go wrong
This is an early Phase 1 trial, so the drug may not prove safe or effective. Side effects and limited benefit are possible, and it only applies to patients with the KRAS G12C mutation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically documented locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS G12C mutation * Measurable disease by RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 Exclusion Criteria: * Patients with malignancy within the last 2 years as specified in the protocol * Patients with untreated or unstable brain metastases * Patients with known hypersensitivity to BBO-8520 or its excipients * For Cohorts 1b and 2b: * Patients with a known hypersensitivity to pembrolizumab or its excipients * Patients with active autoimmune disease of history of autoimmune disease that might recur * Patients with a history of interstitial lung disease/pneumonitis that required steroids, or current interstitial lung disease/pneumonitis Other inclusion/exclusion criteria may apply

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

lung carcinoma lung neoplasm metastatic malignant neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced lung carcinoma KRAS G12C Metastatic lung cancer Metastatic non-small cell lung cancer Non-small cell lung cancer NSCLC

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    38 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Cross Cancer Institute

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Flinders Medical Centre

    RECRUITING

    Bedford Park, South Australia, 5042, Australia

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Henry Ford Cancer - Detroit

    RECRUITING

    Detroit, Michigan, 48282, United States

  • Hospital Universitario Quirónsalud Madrid

    RECRUITING

    Madrid, 28223, Spain

  • Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Jewish General Hospital

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Juravinski Cancer Centre

    RECRUITING

    Hamilton, Ontario, L8V 5C2, Canada

  • Kinghorn Cancer Centre

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

  • Linear Clinical Research

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • NEXT Oncology

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Northwest Medical Specialties

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Norwalk Hospital

    RECRUITING

    Norwalk, Connecticut, 06850, United States

  • O'Neal Comprehensive Cancer Center at UAB

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • OSF Saint Francis Medical Center

    RECRUITING

    Peoria, Illinois, 61603, United States

  • Oncology Consultants Texas Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Peninsula & South Eastern Hematology and Oncology Group (PAS)

    RECRUITING

    Frankston, Victoria, 3199, Australia

  • Perlmutter Cancer Center - NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3051, Australia

  • Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • START Barcelona - Hospital HM Nou Delfos

    RECRUITING

    Barcelona, 08023, Spain

  • START Madrid - Hospital Universitario Fundación Jiménez Díaz

    RECRUITING

    Madrid, 28040, Spain

  • The Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • The Queen Elizabeth Hospital

    RECRUITING

    Woodville South, South Australia, 5011, Australia

  • UCLA Health - Santa Monica Cancer Care

    RECRUITING

    Santa Monica, California, 90404, United States

  • USOR - Oncology Associates of Oregon, P.C

    RECRUITING

    Eugene, Oregon, 97401, United States

  • USOR - Texas Oncology - (DFW) Waco

    RECRUITING

    Waco, Texas, 76710, United States

  • University of California - San Diego Moores Cancer Center

    RECRUITING

    La Jolla, California, 92093, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Colorado Cancer Center

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66205, United States

  • University of Maryland Marlene & Stewart Greenebaum Comprehensive Cancer Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • Vall d'Hebron University Hospital

    RECRUITING

    Horta-Guinardó, Barcelona, 08035, Spain

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

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Other studies related to the condition(s) this trial covers.