Trial 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)
NCT ID:
NCT05856695
Condition:
Small Cell Lung Cancer Extensive Stage
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Paclitaxel
Carboplatin
Durvalumab
Conditions: Keywords:
IFCT
SCLC
SCLC Extensive Stage
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Carboplatin + Paclitaxel + Durvalumab
Description:
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
Arm group label:
Carboplatin + Paclitaxel + Durvalumab
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 synergy with immunotherapy than the
standard etoposide and carboplatin.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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.
2. Patients diagnosed with histologically confirmed SCLC
3. 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.
4. 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.
5. Age ≥ 18 years.
6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 (see
Appendix 1).
7. Body weight >30 kg.
8. 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).
9. 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.
10. 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.
11. Patient must have a life expectancy of at least 12 weeks.
12. Patient covered by a national health insurance.
Exclusion Criteria:
1. Non-small cell lung cancer (NSCLC) or combined SCLC and NSCLC.
2. Prior systemic anticancer therapy for SCLC.
3. Radiotherapy needed at initiation of treatment.
4. 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.
5. 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.
6. History of leptomeningeal carcinomatosis.
7. Symptomatic congestive heart failure, uncontrolled hypertension, unstable angina,
cardiac arrhythmia or clinically uncontrolled heart disease.
8. Mean QT interval corrected (QTc) ≥470 ms.
9. 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.
10. Serum sodium <125 mmol/L unless corrective treatment prior to initiation of study
treatment.
11. Hypercalcemia despite corrective treatment (corrected calcemia = Calcium (mmol) +
[(40- albumin (g)) x 0.025]).
12. History of allogenic organ transplantation.
13. Immunosuppressive systemic therapy (cyclophosphamide, aziathioprine, methotrexate,
thalidomide and TNF inhibitor) within 28 days prior to inclusion.
14. 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.
15. Serious chronic gastrointestinal conditions associated with diarrhea
16. 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.
17. 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.
18. 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).
19. Any medical or personal that would make the patient unable to comply with study
procedures and/or could interfere with the patient safety.
20. 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.
21. 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).
22. 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.
23. 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.
24. Known allergy or hypersensitivity to study treatment or any excipient.
25. Concomitant treatment with another experimental treatment or participation in
another clinical trial.
26. Patient who is subject to legal protection or who is unable to express his will.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Abbeville - CH
Address:
City:
Abbeville
Country:
France
Status:
Recruiting
Contact:
Last name:
Olivier LELEU, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Olivier LELEU, Dr
Email:
Principal Investigator
Facility:
Name:
Amiens - Clinique de l'Europe
Address:
City:
Amiens
Country:
France
Status:
Recruiting
Contact:
Last name:
Charles DAYEN, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Charles DAYEN, Dr
Email:
Principal Investigator
Facility:
Name:
Angers - CHU
Address:
City:
Angers
Country:
France
Status:
Recruiting
Contact:
Last name:
Youssef OULKHOUIR, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Youssef OULKHOUIR, Dr
Email:
Principal Investigator
Facility:
Name:
Besançon - CHU
Address:
City:
Besançon
Country:
France
Status:
Recruiting
Contact:
Last name:
Hamadi ALMOTLAK, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Hamadi ALMOTLAK, Dr
Email:
Principal Investigator
Facility:
Name:
Bordeaux - CHU
Address:
City:
Bordeaux
Country:
France
Status:
Recruiting
Contact:
Last name:
Charlotte DOMBLIDES, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Charlotte DOMBLIDES, Dr
Email:
Principal Investigator
Facility:
Name:
Boulogne - Ambroise Paré
Address:
City:
Boulogne-Billancourt
Country:
France
Status:
Recruiting
Contact:
Last name:
Etienne GIROUX LEPRIEUR, Pr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Etienne GIROUX LEPRIEUR, Pr
Email:
Principal Investigator
Facility:
Name:
Caen - CHU Côte de Nacre
Address:
City:
Caen
Zip:
14000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Jeannick MADELAINE, Dr
Email:
contact@ifct.fr
Facility:
Name:
Chambéry - CH
Address:
City:
Chambéry
Country:
France
Status:
Recruiting
Contact:
Last name:
Anne BARANZELLI, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Anne BARANZELLI, Dr
Email:
Principal Investigator
Facility:
Name:
Cholet - CH
Address:
City:
Cholet
Country:
France
Status:
Recruiting
Contact:
Last name:
Philippe MASSON, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Philippe MASSON, Dr
Email:
Principal Investigator
Facility:
Name:
Colmar - CH
Address:
City:
Colmar
Country:
France
Status:
Recruiting
Contact:
Last name:
Lionel MOREAU, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Lionel MOREAU, Dr
Email:
Principal Investigator
Facility:
Name:
Annemasse - CH
Address:
City:
Contamine-sur-Arve
Country:
France
Status:
Recruiting
Contact:
Last name:
Philippe ROMAND, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Philippe ROMAND, Dr
Email:
Principal Investigator
Facility:
Name:
Créteil - CHI
Address:
City:
Créteil
Country:
France
Status:
Recruiting
Contact:
Last name:
Jean Bernard AULIAC, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Jean Bernard AULIAC, Dr
Email:
Principal Investigator
Facility:
Name:
Dijon - CHU Bocage
Address:
City:
Dijon
Country:
France
Status:
Recruiting
Contact:
Last name:
Ayoube ZOUAK, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Ayoube ZOUAK, Dr
Email:
Principal Investigator
Facility:
Name:
Grenoble - CHU
Address:
City:
Grenoble
Country:
France
Status:
Recruiting
Contact:
Last name:
Denis MORO-SIBILOT, Pr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Denis MORO-SIBILOT, Pr
Email:
Principal Investigator
Facility:
Name:
Le Mans - CHG
Address:
City:
Le Mans
Country:
France
Status:
Recruiting
Contact:
Last name:
Olivier MOLINIER, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Olivier MOLINIER, Dr
Email:
Principal Investigator
Facility:
Name:
Lyon - URCOT
Address:
City:
Lyon
Country:
France
Status:
Recruiting
Contact:
Last name:
Sébastien COURAUD, Pr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Sébastien COURAUD, Pr
Email:
Principal Investigator
Facility:
Name:
Marseille - APHM
Address:
City:
Marseille
Country:
France
Status:
Recruiting
Contact:
Last name:
Laurent GREILLIER, Pr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Laurent GREILLIER, Pr
Email:
Principal Investigator
Facility:
Name:
Marseille - Hôpital Européen
Address:
City:
Marseille
Country:
France
Status:
Recruiting
Contact:
Last name:
Jacques LE TREUT, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Jacques LE TREUT, Dr
Email:
Principal Investigator
Facility:
Name:
CHU Montpellier
Address:
City:
Montpellier
Zip:
34295
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Benoit ROCH
Email:
contact@ifct.fr
Facility:
Name:
Morlaix - CH
Address:
City:
Morlaix
Country:
France
Status:
Recruiting
Contact:
Last name:
Karim AMRANE, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Karim AMRANE, Dr
Email:
Principal Investigator
Facility:
Name:
Orléans - CHR
Address:
City:
Orléans
Country:
France
Status:
Recruiting
Contact:
Last name:
Adrien DIXMIER, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Adrien DIXMIER, Dr
Email:
Principal Investigator
Facility:
Name:
Paris - Bichat
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Valérie GOUNANT, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Valérie GOUNANT, Dr
Email:
Principal Investigator
Facility:
Name:
Paris - Hôpital Cochin
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Marie WISLEZ, Pr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Marie WISLEZ, Pr
Email:
Principal Investigator
Facility:
Name:
Paris - Tenon
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Jacques CADRANEL, Pr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Jacques CADRANEL, Pr
Email:
Principal Investigator
Facility:
Name:
Rennes - CHU
Address:
City:
Rennes
Country:
France
Status:
Recruiting
Contact:
Last name:
Charles RICORDEL, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Charles RICORDEL, Dr
Email:
Principal Investigator
Facility:
Name:
Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg
Address:
City:
Strasbourg
Zip:
67091
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Céline MASCAUX, Pr
Facility:
Name:
Toulon - Sainte Anne HIA
Address:
City:
Toulon
Country:
France
Status:
Recruiting
Contact:
Last name:
Olivier BYLICKI, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Olivier BYLICKI, Dr
Email:
Principal Investigator
Facility:
Name:
CHU Toulouse
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Laurence BIGAY-GAME, Dr
Facility:
Name:
Tours - CHU
Address:
City:
Tours
Country:
France
Status:
Recruiting
Contact:
Last name:
Eric PICHON, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Eric PICHON, Dr
Email:
Principal Investigator
Facility:
Name:
Vandoeuvre-lès-Nancy - CRLCC
Address:
City:
Vandœuvre-lès-Nancy
Country:
France
Status:
Recruiting
Contact:
Last name:
Christelle CLEMENT-DUCHENE, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Christelle CLEMENT-DUCHENE, Dr
Email:
Principal Investigator
Facility:
Name:
Villefranche sur Saône - CH
Address:
City:
Villefranche-sur-Saône
Country:
France
Status:
Recruiting
Contact:
Last name:
Lionel FALCHERO, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Investigator:
Last name:
Lionel FALCHERO, Dr
Email:
Principal Investigator
Start date:
November 17, 2023
Completion date:
February 2028
Lead sponsor:
Agency:
Intergroupe Francophone de Cancerologie Thoracique
Agency class:
Other
Source:
Intergroupe Francophone de Cancerologie Thoracique
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05856695
