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Experimental lung cancer combo trial ends early

NCT ID NCT04914897

Disease control Sponsor: Sanofi 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 2 trial tested a new drug called THOR-707 (Pegenzileukin) combined with other cancer treatments, including pembrolizumab, in 106 people with advanced lung cancer or pleural mesothelioma. The goal was to see if the combination could shrink tumors. However, the study was terminated early, so the full results are not available.

What this could mean

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

Active substance
THOR-707 (Pegenzileukin) combined with pembrolizumab
What this could lead to
If successful, this combination could offer a new treatment option for people with certain types of lung cancer or mesothelioma.
What could go wrong
The trial was terminated early, so we don't have full results. It's unclear if the combination is effective or safe enough to continue.

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

106 people

The number who actually took part.

Started

Sep 2021

Finished

Oct 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: * Participant must have been ≥18 years of age (or country's legal age of majority if \>18 years), at the time of signing the informed consent. * Histologically or cytologically confirmed diagnosis of Stage IV NSCLC (cohorts A1, A2, and B1), or unresectable malignant pleural mesothelioma (cohort C1). * Cohort A1: PD-L1 expression TPS ≥ 50% * Cohort A2: PD-L1 expression TPS 1 - 49% * Prior anticancer therapy * Cohorts A1 and A2: No prior systemic therapy for advanced/metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the development of metastatic disease. * Cohort B1: One prior anti-PD1/PD-L1 regimen (may include chemotherapy) plus one additional chemotherapy regimen * Cohort C1: One or two prior systemic treatments that include pemetrexed-based regimen in combination with platinum agent. * All cohorts must have had a measurable disease * Mandatory baseline biopsy for the first 20 participants to enroll in cohorts A1, A2 * Cohort B1: Based on the Investigator's judgment, either docetaxel or pemetrexed is not the best treatment option for the participant. * Females were eligible to participate if they were not pregnant or breastfeeding, not a woman of childbearing potential (WOCBP) or are a WOCBP that agrees: * to use approved contraception method and submit to regular pregnancy testing prior to treatment and for 150 days after discontinuing study treatment * to refrain from donating or cryopreserving eggs for 150 days after discontinuing study treatment. * Males were eligible to participate if they agree to refrain from donating or cryopreserving sperm, and either abstain from heterosexual intercourse OR use approved contraception during study treatment and for at least 210 days after discontinuing study treatment. * Capable of giving signed informed consent. Exclusion Criteria: Participants were excluded from the study if any of the following criteria applied: * Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 2. * Poor bone marrow reserve * Poor organ function * Participants with baseline SpO2 ≤ 92%. * Active brain metastases or leptomeningeal disease. * History of allogenic tissue/solid organ transplant * Last administration of prior antitumor therapy or any investigational treatment within 28 days or less than 5 times the half-life, whichever is shorter; major surgery or local intervention within 28 days. * Has received prior IL-2-based anticancer treatment. * Comorbidity requiring corticosteroid therapy * Antibiotic use (excluding topical antibiotics) ≤14 days prior to first dose of IMP * Severe or unstable cardiac condition within 6 months prior to starting study treatment * Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years * Known second malignancy either progressing or requiring active treatment within the last 3 years * Cohorts A1, A2, and C1: Prior treatment with an agent (approved or investigational) that blocks the PD1/PD-L1 pathway (participants who joined a study with an anti-PD1/PD-L1 but have written confirmation they were on control arm are allowed). * Receipt of a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted. The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

malignant pleural mesothelioma Mesothelioma, Malignant non-small cell lung carcinoma pleural mesothelioma

As listed by the trial registrant

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

Non-small cell lung cancer Pleural mesothelioma

Contacts and locations

Locations

  • Investigational Site Number : 0320002

    CABA, Buenos Aires, 1430, Argentina

  • Investigational Site Number : 0360002

    Richmond, Victoria, 3121, Australia

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8420383, Chile

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7500921, Chile

  • Investigational Site Number : 1520003

    Temuco, 4800827, Chile

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana de Santiago, 7500713, Chile

  • Investigational Site Number : 1520005

    Santaigo, Reg Metropolitana de Santiago, 8241470, Chile

  • Investigational Site Number : 1580002

    Tainan, 704, Taiwan

  • Investigational Site Number : 1580003

    Taichung, 404, Taiwan

  • Investigational Site Number : 1580005

    Taipei, Taiwan

  • Investigational Site Number : 2500001

    Saint-Herblain, 44800, France

  • Investigational Site Number : 2500003

    Toulouse, 31059, France

  • Investigational Site Number : 2500005

    Paris, 75018, France

  • Investigational Site Number : 2500006

    Bordeaux, France

  • Investigational Site Number : 3800001

    Rozzano, Milano, 20089, Italy

  • Investigational Site Number : 3800002

    Orbassano, Torino, 10043, Italy

  • Investigational Site Number : 3800004

    Milan, 20133, Italy

  • Investigational Site Number : 3800005

    Aviano (PN), Friuli Venezia Giulia, 33081, Italy

  • Investigational Site Number : 3800006

    Bologna, 40138, Italy

  • Investigational Site Number : 3800008

    Padova, 35128, Italy

  • Investigational Site Number : 3920001

    Sapporo, Hokkaido, 003-0804, Japan

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 06351, South Korea

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number : 4100003

    Seoul, Seoul-teukbyeolsi, 05505, South Korea

  • Investigational Site Number : 6160001

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Investigational Site Number : 6160002

    Poznan, Greater Poland Voivodeship, 60-693, Poland

  • Investigational Site Number : 6160003

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Investigational Site Number : 6160004

    Olsztyn, Warmian-Masurian Voivodeship, 10-357, Poland

  • Investigational Site Number : 7240001

    Madrid, 28041, Spain

  • Investigational Site Number : 7240002

    Madrid, 28034, Spain

  • Investigational Site Number : 7240003

    Girona, Girona [Gerona], 17007, Spain

  • Investigational Site Number : 7240004

    Madrid, Madrid, Comunidad de, 28046, Spain

  • Investigational Site Number : 7240006

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Thomas Jefferson University - North East Site Number : 8401009

    Philadelphia, Pennsylvania, 19114, United States

  • Thomas Jefferson University Hospital Site Number : 8400009

    Philadelphia, Pennsylvania, 19107, United States

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