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New immunotherapy combo shows promise for tough lung cancer

NCT ID NCT04063163

Disease control Sponsor: Shanghai Henlius Biotech Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 3 trial tested whether adding an experimental immunotherapy drug called HLX10 to standard chemotherapy could help people with extensive-stage small cell lung cancer live longer. The study enrolled 585 people who had not received prior treatment. Participants were randomly assigned to receive either HLX10 plus chemo or a placebo plus chemo. The main goal was to see if the combination improved overall survival.

What this could mean

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

Active substance
HLX10 (a PD-1 inhibitor) combined with chemotherapy (carboplatin and etoposide)
What this could lead to
If successful, this combination could become a new first-line treatment option for extensive-stage small cell lung cancer, potentially improving survival.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. Adding immunotherapy to chemo may increase side effects, and not all patients may benefit.

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

585 people

The number who actually took part.

Started

Sep 2019

Finished

May 2024

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 diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system). * No prior systemic therapy for ES-SCLC * Major organs are functioning well * Participant must keep contraception Exclusion Criteria: * Histologically or cytologically confirmed mixed SCLC. * Known history of severe allergy to any monoclonal antibody. * Known hypersensitivity to carboplatin or etoposide. * Pregnant or breastfeeding females. * Patients with a known history of psychotropic drug abuse or drug addiction. * Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.

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Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

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

Extensive-stage small-cell lung cancer

Contacts and locations

Locations

  • Arkhangelsk Clinical Oncology Dispensary

    Arkhangelsk, Russia

  • Institute for Personalized Medicine

    Tbilisi, Georgia

  • Komunalnyi zaklad Miska bahato

    Dnipropetrovsk, Ukraine

  • Medipol Mega Hospital

    Istanbul, Turkey (Türkiye)

  • Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi

    Lodz, Poland

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