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Small Cell Lung Cancer Extensive StagePhase 2TAXIONCT05856695

Durvalumab Plus Etoposide-free Chemotherapy in First-line Treatment of Extensive-disease Small-sell Lung Cancer (SCLC)

A Phase 2 study testing Carboplatin + Paclitaxel + Durvalumab in people with Small Cell Lung Cancer Extensive Stage, run by Intergroupe Francophone de Cancerologie Thoracique at 31 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The current study is intended to be a "proof of concept" to evaluate the potential value of synergy between paclitaxel carboplatin and immunotherapy. If a signal clearly shows superiority over the CASPIAN data , we will have arguments to think that the combination of paclitaxel and carboplatin is more suitable for… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer Extensive Stage
What is being tested?
Carboplatin + Paclitaxel + Durvalumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
31 sitesFrance
Study dates
17 Nov 2023to Nov 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Informed consent.
  • Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.
  • Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
  • Patients diagnosed with histologically confirmed SCLC
  • Extended-Stage Disease at time of accrual according to the criteria of the Veteran's Administration Lung Cancer Group (VALG). Extended disease is defined as going beyond hemithorax and supraclavicular ganglionic areas, and malignant pleural effusions will be considered extended diseases.
  • At least one measurable target lesion according to RECIST v1.1 per investigator assessment.The radiological assessment has to be done within the timelines indicated.
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  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 (see Appendix 1).
  • Body weight >30 kg.
  • Adequate biological functions:
  • Creatinine clearance ≥ 45 ml/min (Cockroft or MDRD or CKD-epi);
  • Hemoglobin ≥ 9.0 g / dL
  • Neutrophils ≥ 1500 /μL
  • Platelets ≥ 100 000 /μL
  • Bilirubin ≤ 1.5 x normal except for patients with proved Gilbert syndrome (≤ 3 x ULN)
  • ALT and AST ≤ 2.5 x normal upper value except in case of liver metastases (≤ 5 x normal upper value).
  • Woman patients who are no longer likely to procreate (physiologically unfit to carry a pregnancy), which includes:
  • Hysterectomy
  • Ovariectomy
  • Bilateral tubal ligation
  • Postmenopausal women:
  • Patients not using hormone replacement therapy should have had a complete cessation of menstruation for at least one year and be over 45 years old, or, if in doubt, have an FSH (Follicle Stimulating Hormone)> 40 mIU/mL and a Estradiol value<40 μg/mL (<150 pmol/L)
  • Patients using hormone replacement therapy should have had a complete cessation of menstruation for at least one year and be over 45 years of age or have evidence of menopause (FSH and estradiol levels) prior to initiation of hormone replacement therapy.
  • Woman patients who are of childbearing potential are eligible:
  • They must have a negative serum pregnancy test within the week preceding the first dose of treatment and preferably as close as possible to the first dose.
  • They must agree to use methods of contraception acceptable for IFCT, when used in accordance with the product leaflet and the doctor's instructions, are as follows:
  • An intrauterine device with a failure rate of less than 1% per year
  • Male sterilized partner (vasectomy with azoosperm documentation) prior to inclusion of the patient and who is the sole partner of the patient.
  • Total abstinence from sexual intercourse 14 days before the start of treatment, throughout the duration of treatment and at least 21 days after the last dose of treatment.
  • Double-barrier contraception: condom and cape (diaphragm or cervical / vaginal cap) with a vaginal spermicidal agent (foam / gel / film / cream / suppository).
  • Oral, combined or progestin contraceptive alone.
  • Injectable progestin.
  • Levonorgestrel implant.
  • Vaginal ring impregnated with estrogen.
  • Percutaneous contraceptive patch. Contraceptive methods should be used throughout the course of treatment and should be maintained for 6 months after the end of treatment.
  • Male subjects who are sexually active with a woman of childbearing potential are eligible if an efficacious contraception method should be used during the treatment and during the 6 months following the last dose.
  • Patient must have a life expectancy of at least 12 weeks.
  • Patient covered by a national health insurance.

Who cannot join

  • Non-small cell lung cancer (NSCLC) or combined SCLC and NSCLC.
  • Prior systemic anticancer therapy for SCLC.
  • Radiotherapy needed at initiation of treatment.
  • Major surgical procedure (as defined by the Investigator) within 28 days prior initiation of treatment.
  • Note: Local surgery of isolated lesions for palliative intent is acceptable.
  • Symptomatic brain metastasis. Note: patient with asymptomatic or treated and stable brain metastasis for at least 1 month prior to study treatment are eligible. Patients with suspected brain metastases at screening should have a CT/MRI of the brain prior to study entry.
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  • History of leptomeningeal carcinomatosis.
  • Symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, cardiac arrhythmia or clinically uncontrolled heart disease.
  • Mean QT interval corrected (QTc) ≥470 ms.
  • Corticosteroid therapy at a dose greater than 10 mg per day of prednisolone or equivalent for more than 10 days within 14 days prior initiation of treatment.
  • Note: Intranasal, inhaled, topical steroids, or local steroid injections and steroids as premedication for hypersensitivity reactions are allowed.
  • Serum sodium <125 mmol/L unless corrective treatment prior to initiation of study treatment.
  • Hypercalcemia despite corrective treatment (corrected calcemia = Calcium (mmol) + [(40- albumin (g)) x 0.025]).
  • History of allogenic organ transplantation.
  • Immunosuppressive systemic therapy (cyclophosphamide, aziathioprine, methotrexate, thalidomide and TNF inhibitor) within 28 days prior to inclusion.
  • Active or prior documented autoimmune disease or inflammatory disorders including but is not limited to inflammatory bowel disease (colitis or Crohn's disease), diverticulitis (with the exception of diverticulosis), sarcoidosis syndrome, myasthenia gravis, lupus erythematosus, rheumatoid arthritis, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain Barré's syndrome, multiple sclerosis, vasculitis and glomerulonephritis. Patients with severe psoriasis (10% of your body's surface area) are not eligible.
  • Note: The following are exceptions are listed below:
  • patients with vitiligo or alopecia,
  • patients with history of autoimmune hypothyroidism treated with a stable dose of hormone replacement therapy,
  • any chronic skin condition that does not require systemic therapy,
  • patients without active disease in the last 5 years may be included but only after consultation with the investigator,
  • patients with celiac disease controlled by diet alone,
  • patients with diabetes treated with insulin.
  • Serious chronic gastrointestinal conditions associated with diarrhea
  • History of idiopathic pulmonary fibrosis, organized pneumonia (i.e., bronchiolitis obliterans), drug-induced pulmonary pathology or active signs of pneumonia, interstitial lung disease (whatever the cause) detected on the pulmonary CT-scan.
  • History of cancer Note: Patients with a history of cancer for more than 3 years are eligible if they have been treated and considered cured. Patients with a history of basal cell carcinoma of the skin or in situ carcinoma of the cervix are eligible.
  • Concomitant anti-cancer treatment or within 3 years prior to the start of study treatment, including chemotherapy, immunotherapy, hormone therapy, biotherapy or anti-angiogenic treatment (VEGF inhibitors or VEGFR inhibitors).
  • Any medical or personal that would make the patient unable to comply with study procedures and/or could interfere with the patient safety.
  • Receipt of live, attenuated vaccine within 30 days prior to the first dose of study drugs.
  • Note: Patients, if enrolled, should not receive live vaccine whilst receiving study drugs and up to 30 days after the last dose of study drugs. Nucleic acid vaccines, inactivated vaccines against COVID-19 are allowed.
  • Ongoing or active infection including:
  • COVID-19.
  • Tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice).
  • Hepatitis B virus (known positive HBV surface antigen [HbsAg] result). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HbsAg) are eligible.
  • Positive hepatitis C virus (HCV).
  • Patients with a known history of a positive test for HIV or known AIDS who have not received effective antiretroviral therapy (ART) for the last 4 weeks and who have an HIV viral load >200 copies/mL, regardless of CD4+ T-cell count. Paraneoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or clinical symptomatology suggesting worsening of PNS.
  • Pregnant or lactating woman. Note: Women who are breastfeeding should stop breastfeeding before the first dose of treatment, throughout the course of treatment and at least 3 months after the last dose of treatment.
  • Known allergy or hypersensitivity to study treatment or any excipient.
  • Concomitant treatment with another experimental treatment or participation in another clinical trial.
  • Patient who is subject to legal protection or who is unable to express his will.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

France31 sites

  • Abbeville - CH

    Abbeville

  • Amiens - Clinique de l'Europe

    Amiens

  • Angers - CHU

    Angers

  • Besançon - CHU

    Besançon

  • Bordeaux - CHU

    Bordeaux

  • Boulogne - Ambroise Paré

    Boulogne-Billancourt

  • Caen - CHU Côte de Nacre

    Caen, 14000

  • Chambéry - CH

    Chambéry

  • Cholet - CH

    Cholet

  • Colmar - CH

    Colmar

  • Annemasse - CH

    Contamine-sur-Arve

  • Créteil - CHI

    Créteil

  • Dijon - CHU Bocage

    Dijon

  • Grenoble - CHU

    Grenoble

  • Le Mans - CHG

    Le Mans

  • Lyon - URCOT

    Lyon

  • Marseille - APHM

    Marseille

  • Marseille - Hôpital Européen

    Marseille

  • CHU Montpellier

    Montpellier, 34295

  • Morlaix - CH

    Morlaix

  • Orléans - CHR

    Orléans

  • Paris - Bichat

    Paris

  • Paris - Hôpital Cochin

    Paris

  • Paris - Tenon

    Paris

  • Rennes - CHU

    Rennes

  • Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091

  • Toulon - Sainte Anne HIA

    Toulon

  • CHU Toulouse

    Toulouse, 31059

  • Tours - CHU

    Tours

  • Vandoeuvre-lès-Nancy - CRLCC

    Vandœuvre-lès-Nancy

  • Villefranche sur Saône - CH

    Villefranche-sur-Saône

Other trials in France

About this study

Official title: A Phase II Study Assessing the Efficacy of Etoposide Free Chemotherapy Plus Durvalumab (MEDI4736) in First Line Extensive Disease Small Cell Lung Cancer (SCLC)

The current study is intended to be a "proof of concept" to evaluate the potential value of synergy between paclitaxel carboplatin and immunotherapy. If a signal clearly shows superiority over the CASPIAN data , we will have arguments to think that the combination of paclitaxel and carboplatin is more suitable for synergy with immunotherapy than the standard etoposide and carboplatin.

Being tested
Carboplatin + Paclitaxel + Durvalumab
Keywords
IFCT, SCLC, SCLC Extensive Stage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carboplatin + Paclitaxel + DurvalumabDrug

    Carboplatin AUC 6, day 1 of three-week cycle for four cycles Paclitaxel 200 mg/m² day 1 of a three-week cycle for four cycles Durvalumab 1500 mg every 3 weeks for 4 cycles followed by 1500 mg maintenance every 4 weeks until progression, unacceptable toxicity, or consent withdrawal

Study groups in NCT05856695
Study groupRoleWhat they receive
Carboplatin + Paclitaxel + DurvalumabExperimentalCarboplatin AUC 6, day 1 of three-week cycle for four cycles Paclitaxel 200 mg/m² day 1 of a three-week cycle for four cycles Durvalumab 1500 mg every 3 weeks for 4 cycles followed by 1500 mg maintenance every 4 weeks until progression, unacceptable toxicity, or consent withdrawal
Receives: Drug: Carboplatin + Paclitaxel + Durvalumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall Survival (OS) defined as the time from the date of first dose of study drug to the date of death due to any cause

    Measured: At 12 months

Secondary outcomes (7)

  1. Best response rate (RECIST 1.1)

    Best response rate (RECIST 1.1) which is defined as the percentage of subjects with a complete response (CR) or partial response (PR) determined by Investigator review and by independent reviewer as per RECIST v1.1 criteria.

    Measured: About 48 months

  2. Overall Survival (OS)

    Overall Survival (OS) defined as the time from the date of first dose of study drug to the date of death due to any cause

    Measured: About 48 months

  3. Overall Survival (OS)

    Overall Survival (OS) defined as the time from the date of first dose of study drug to the date of death due to any cause

    Measured: At 24 months

  4. Overall Survival (OS)

    Overall Survival (OS) defined as the time from the date of first dose of study drug to the date of death due to any cause

    Measured: At 36 months

  5. Progression free survival (PFS)

    Progression free survival (PFS) defined as the time from the date of inclusion to the earliest date of disease progression, as determined by Investigator review and by independent reviewer of radiographic disease assessments per RECIST v1.1, or death due to any cause

    Measured: About 48 months

  6. Safety and tolerability of paclitaxel carboplatin and durvalumab.

    Incidence, nature, and severity of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)

    Measured: About 48 months

  7. Quality of life of patients

    Change from baseline of Quality of life assessment using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30 LC13) at all scheduled time points.

    Measured: About 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2023
  2. Study start17 Nov 2023
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
67 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05856695
Sponsor's protocol ID
IFCT-2203
Acronym
TAXIO
Status last verified
Mar 2026
First submitted
4 May 2023
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin + Paclitaxel + Durvalumab in people with Small Cell Lung Cancer Extensive Stage, run by Intergroupe Francophone de Cancerologie Thoracique at 31 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 38 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: At 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05856695.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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