New lung cancer drug aims to match Keytruda's success

NCT ID NCT06939595

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether a new drug called CT-P51 works as well as the established immunotherapy Keytruda for people with advanced non-squamous non-small cell lung cancer that has not been treated before. All participants also receive standard chemotherapy. The study compares how many patients' tumors shrink or disappear with each treatment combination.

What this could mean

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

Active substance
CT-P51 (a biosimilar to Keytruda)
What this could lead to
If CT-P51 works as well as Keytruda, it could offer a more affordable treatment option for people with this type of lung cancer.
What could go wrong
This is an early comparison study. CT-P51 may not be as effective or safe as Keytruda, and results may not apply to all lung cancer patients.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

225 people

The number who actually took part.

Started

Jan 2025

Expected to finish

Jul 2028

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: * Stage IV, non squamous NSCLC * Have not received any prior systemic anti-cancer therapy for metastatic NSCLC * Have at least 1 measurable lesion per RECIST version 1.1 Exclusion Criteria: * Have predominantly squamous cell histology NSCLC. * Hypersensitivity or contraindication to any component of the study drug, pemetrexed and cisplatin or carboplatin

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • ltd "Institute of Clinical Oncology"

    Tbilisi, Georgia

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