Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug combo targets tough lung cancer mutation

NCT ID NCT06816992

Disease control Sponsor: ORIC Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a new oral drug called ORIC-114 combined with an injectable drug, amivantamab, in people with advanced lung cancer that has a specific genetic change (EGFR exon20 insertion). The study aims to find the safest dose and see if the combination shrinks tumors. About 76 participants will be enrolled.

What this could mean

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

Active substance
ORIC-114 (oral drug) plus amivantamab (injectable drug)
What this could lead to
If this combination works, it could offer a new treatment option for people with a hard-to-treat form of lung cancer that has specific genetic changes.
What could go wrong
This is an early Phase 1b trial with only 76 participants, so the main goal is safety and dosing, not proof of effectiveness. The combination may cause side effects or not work better than existing treatments.
Why investors are watching

ORIC Pharmaceuticals is testing its drug ORIC-114 with amivantamab in patients with a specific type of lung cancer, EGFR exon 20 insertion mutant NSCLC. For a small company, this early-stage trial is a key test of whether its drug can work safely and show signs of controlling the disease, which could shape its future value.

If it works: If the combination shows a good safety profile and clear tumor control, ORIC could advance the drug to later-stage testing. That would validate its science and potentially attract partnership interest.

If it fails: The trial could fail to show enough benefit or produce safety problems, which would set the program back. Early-stage trials often fail, so a disappointing result would be a serious blow for a company of this size.

AI-written from the trial record. Speculative, and not investment advice.

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 76 people

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

Started

Feb 2025

Expected to finish

Dec 2027

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 or cytologically confirmed metastatic NSCLC with a documented EGFR exon 20 insertion mutation as determined locally by any nucleic acid-based diagnostic testing method; all tests should be performed in a CLIA certified or equivalently accredited laboratory * Prior Therapies: 1. Dose Escalation: Patients may have previously received and progressed on or after platinum-based chemotherapy or may be treatment naïve 2. Dose Expansion: Patients must not have received any prior therapy; at time of enrollment, patients must decline, or be ineligible for all available standard of care therapies with proven benefit * Agreement and ability to undergo a pretreatment biopsy, provided the procedure is clinically feasible and not deemed unsafe by the investigator * Measurable disease according to RECIST 1.1 * Patients with asymptomatic CNS metastases are eligible * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ function Exclusion Criteria: * Known small cell lung cancer transformation * Leptomeningeal disease * Spinal cord compression not definitively treated with surgery or radiation * Prior immunotherapy * Past medical history of interstitial lung disease (ILD), drug induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD * Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably impact absorption of ORIC-114

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for EGFR exon 20 insertion mutations are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

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

EGFR exon 20 insertion mutations EGFR-mutated NSCLC NSCLC Solid tumors

How to take part

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

  1. The places running it

    4 sites in 3 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

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Peter MacCallum Cancer Centre

    NOT_YET_RECRUITING

    Melbourne, Victoria, 03000, Australia

  • The Princess Margaret Hospital

    NOT_YET_RECRUITING

    Toronto, Ontario, M5G 1Z5, Canada

  • Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

More trials for these conditions

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