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Tiny study probes risks of lung cancer combo therapy

NCT ID NCT03705806

Knowledge-focused Sponsor: University Health Network, Toronto 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 12 people with stage IV non-small cell lung cancer who received both palliative chest radiation and an immunotherapy drug (nivolumab or pembrolizumab). The goal was to track side effects like radiation-related toxicities and patient quality of life. Researchers hope to learn how to better manage these combined treatments, but the small size means findings are limited.

What this could mean

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

Active substance
Radiation therapy (30 Gy in 10 fractions) combined with PD-1 inhibitors (nivolumab or pembrolizumab)
What this could lead to
If successful, this could help doctors better understand and manage side effects when combining radiation and immunotherapy for advanced lung cancer.
What could go wrong
This is a very small observational study (12 people) with no control group, so results may not apply broadly. It only looks at side effects, not whether the combination works better.

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.

Participants

12 people

The number who actually took part.

Started

Oct 2018

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

This study will include a population of patients with metastatic NSCLC on first or second line immunotherapy who have an indication for palliative thoracic radiation

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: 1. Pathologically confirmed AJCC 7th/8th edition Stage IV adenocarcinoma or squamous cell carcinoma not eligible for curative treatment. 2. Indication and suitability to receive palliative radiotherapy to the thorax (30Gy/10). 3. Receiving or planned to receive nivolumab or pembrolizumab 4. Prior history of systemic chemotherapy is permitted given a washout period of 4 weeks 5. Age 18 or older 6. ECOG Performance Status 0-2 7. Life expectancy greater than 3 months 8. Able and willing to provide informed consent 9. Able to complete patient reported outcome questionnaires Exclusion Criteria: 1. Contraindications to radiotherapy, including a history of SLE, systemic scleroderma, IPF, ataxia telangiectasia 2. Previous history of thoracic radiotherapy with an overlapping field 3. Previous history of checkpoint inhibitor related pneumonitis or esophagitis 4. Pregnancy

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Conditions

The condition(s) this trial relates to.

lung cancer lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

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

Lung cancer Lung cancer, nonsmall cell

Contacts and locations

Locations

  • University Health Network, Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

More trials for these conditions

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