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Gentler chemo combo offers hope for elderly lung cancer patients

NCT ID NCT07020065

Disease control Sponsor: Swiss Cancer Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study is for people aged 70 and older with advanced non-small cell lung cancer who are too frail for standard chemotherapy. It compares a lower-dose chemo plus an immunotherapy drug (cemiplimab) against immunotherapy alone. The goal is to find a treatment that works well but causes fewer side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 156 people

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

Started

Apr 2026

Expected to finish

Sep 2030

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.

Ages

70 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: * Informed Consent as documented by signature * Histologically or cytologically confirmed NSCLC. Mixed histology with small-cell component is not allowed. * Metastatic or advanced or recurrent NSCLC without a curative-intent treatment option (surgery or chemo-radiotherapy). * PD-L1 \<50% by local testing (SP 142 excluded) * ≥70 years * ECOG 0-2 * G8 screening score of ≤14 and/or ineligible for full-dose chemotherapy, defined as doses of carboplatin AUC 5, pemetrexed 500 mg/m2, paclitaxel 175 mg/m2, gemcitabine 1200 mg/m2 (as per Investigator) * Life expectancy ≥6 months * Patients with a prior malignancy (except NSCLC, see EC 7.2.2 and 7.2.3) and treated with curative intent are eligible if all treatment of that malignancy was completed at least 2 years before registration and the patient has no evidence of disease at registration. Less than 2 years is acceptable for malignancies with low risk of recurrence and/or no late recurrence, after consultation with CI. * Patients with asymptomatic untreated or symptomatic treated CNS metastases are eligible if corticosteroid dose \<10 mg prednisolone equivalent/day for at least 7 days * Patients must be suitable to receive reduced-dose carboplatin-doublet chemotherapy in combination with immunotherapy including adequate bone marrow, renal and hepatic function as follows: * Hemoglobin ≥90 g/L, neutrophils ≥1.5 G/L, Thrombocytes ≥100G/L * Creatinine clearance (Cockroft-Gault) ≥30 mL/min * ASAT/ALAT ≤2xULN, Bilirubin ≤1.5xULN (≤3xULN for patients with Gilbert's disease), * Men agree not to donate sperm or father a child during trial treatment and until 6 months after the last dose of trial treatment Exclusion Criteria: * Actionable genomic alteration for 1L treatment (EGFR, ALK, ROS1, RET, NTRK, MET Exon14 skipping). Testing is required for any NSQ-NSCLC or patients with SCC and a smoking history of ≤10py. * Prior systemic treatment for metastatic NSCLC. * Prior chemotherapy and/or immunotherapy in curative-intent treatment for locally advanced NSCLC in the past 6 months. * Oligometastatic treatment concept with induction systemic therapy and planned LAT to all lesions. * High tumor burden with a risk of rapid critical progression, as judged by the Investigator. Careful patient selection is important in order to prevent that patients in the comparator arm are not eligible for receiving add-on reduced-dose chemotherapy anymore if primary progression occurs (e.g., pericardial infiltration, high liver metastasis load etc). * Active, treatment-requiring auto-immune disease in the past 2 years other than vitiligo, alopecia, hypothyroidism, type 1 diabetes or diet-controlled celiac disease. * History of pneumonitis in the past 5 years. * Systemic corticosteroid treatment ≥10 mg/day of prednisolone-equivalent or any other systemic immunosuppressive medication within 7 days prior to first dose of study intervention (except as needed for chemotherapy premedication or for physiologic corticosteroid replacement) * Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first dose of study medication * Uncontrolled infection with HIV, hepatitis B or hepatitis C infection * Receipt of a live vaccine within 4 weeks of start of study medication * Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication * Organ transplant

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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.

Metastatic NSCLC - non-small cell lung cancer

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    17 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • EOC Istituto Oncologico della Svizzera Italiana (IOSI)

    RECRUITING

    Viganello, 6962, Switzerland

  • HFR Fribourg

    RECRUITING

    Fribourg, Villars-sur-Glâne, 1752, Switzerland

  • Hôpital du Valais - Sion

    RECRUITING

    Sion, 1951, Switzerland

  • Hôpitaux Universitaires de Genève

    RECRUITING

    Geneva, 1211, Switzerland

  • Inselspital

    RECRUITING

    Bern, 3010, Switzerland

  • KSW Kantonsspital Winterthur

    RECRUITING

    Winterthur, 8401, Switzerland

  • Kantonsspital - St. Gallen

    RECRUITING

    Sankt Gallen, CH-9007, Switzerland

  • Kantonsspital Aarau

    RECRUITING

    Aarau, CH-5001, Switzerland

  • Kantonsspital Baden

    RECRUITING

    Baden, 5404, Switzerland

  • Kantonsspital Baselland

    RECRUITING

    Bruderholz, 4101, Switzerland

  • Kantonsspital Graubuenden

    RECRUITING

    Chur, CH-7000, Switzerland

  • Kantonsspital Olten - Solothurner Spitäler

    RECRUITING

    Olten, 4600, Switzerland

  • Kantonsspital Winterthur

    RECRUITING

    Winterthur, 8401, Switzerland

  • Spital Thun

    RECRUITING

    Thun, 3600, Switzerland

  • Spital Thurgau AG - Kantonsspital Frauenfeld

    RECRUITING

    Frauenfeld, 8501, Switzerland

  • Stadtspital Zürich Triemli

    RECRUITING

    Zurich, 8063, Switzerland

  • Universitätsspital Basel

    RECRUITING

    Basel, 4031, Switzerland

More trials for these conditions

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