Immunotherapy, Chemotherapy, Radiotherapy and Surgery for Synchronous Oligo-metastatic NSCLC (CHESS)
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|ClinicalTrials.gov Identifier: NCT03965468|
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : July 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer Stage IV Oligometastasis||Drug: Durvalumab Drug: Carboplatin Drug: Paclitaxel Radiation: Stereotactic body radiation therapy (SBRT) Procedure: Surgical resection - definitive local treatment. Radiation: Radical radiotherapy - definitive local treatment.||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre Single Arm Phase II Trial Assessing the Efficacy of Immunotherapy, Chemotherapy and Stereotactic Radiotherapy to Metastases Followed by Definitive Surgery or Radiotherapy to the Primary Tumour, in Patients With Synchronous Oligo-metastatic Non-small Cell Lung Cancer|
|Actual Study Start Date :||November 19, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Immunotherapy, chemotherapy, radiotherapy and surgery
Durvalumab 1500 mg administered intravenously every 3 weeks for the first 4-6 cycles (during chemotherapy);
4-6 cycles of chemotherapy, carboplatin AUC5 every 3 weeks plus paclitaxel 175 mg/m2, every 3 weeks;
Stereotactic body radiotherapy (SBRT) of all oligo-metastatic lesions, in a maximum of 10 treatment fractions over 2 weeks, starting after week one of chemotherapy cycle 1 and completed within four weeks after start of durvalumab treatment;
Restaging at 3 months; if no disease progression, proceed to definitive local treatment (surgical resection of primary tumour or radiotherapy at a minimum dose of 60-66Gy to the primary tumour). Durvalumab continues at 1500 mg intravenously every 4 weeks until progression of disease or for a maximum of 1 year from start of treatment.
Durvalumab is a human monoclonal antibody (mAb) of the immunoglobulin G (IgG) 1 kappa subclass that inhibits binding of PD-L1. Durvalumab is expected to stimulate the patient's antitumour immune response by binding to PD L1 and shifting the balance toward an antitumour response.
Other Name: Imfinzi
Carboplatin belongs to the group of medicines known as alkylating agents. Carboplatin interferes with the growth of cancer cells, which eventually are destroyed.
A compound extracted from the Pacific yew tree Taxus brevifolia with antineoplastic activity. Paclitaxel binds to tubulin and inhibits the disassembly of microtubules, thereby resulting in the inhibition of cell division. This agent also induces apoptosis by binding to and blocking the function of the apoptosis inhibitor protein Bcl-2 (B-cell Leukemia 2).
Radiation: Stereotactic body radiation therapy (SBRT)
SBRT of all oligo-metastatic lesions
Procedure: Surgical resection - definitive local treatment.
Surgical resection of primary tumour for patients with single station, non-bulky tumours.
Radiation: Radical radiotherapy - definitive local treatment.
Conventional or moderately hypo-fractionated radiotherapy to the primary tumour for other tumour stages, or in case of medical inoperability.
- Progression-free survival at 12 months [ Time Frame: Assessed from the date of enrolment to completion of treatment at 12 months. ]Defined as time from date of enrollment until documented progression. Progression is defined as the development of new metastatic lesions or local progression of resected or irradiated metastases or primary tumour, assessed according to RECIST 1.1 criteria.
- Overall survival [ Time Frame: Time from date of enrolment until death from any cause. Assessed for up to 30 months. ]Defined as the time from date of enrolment until death from any cause. Censoring will occur at the last follow-up date.
- Pattern of disease progression [ Time Frame: Assessed from the date of enrolment until progression, from enrolment up to 12 months. ]Defined as the site of first progression. None, locoregional, distant, or both locoregional and distant.
- Response to induction therapy [ Time Frame: Assessed from the start of protocol treatment until the end of the induction phase (restaging at 3-month tumour assessment). ]Defined as the best overall response [complete response (CR) or partial response (PR)] according to RECIST 1.1 criteria.
- Distant progression-free survival [ Time Frame: Assessed from the date of enrolment for up to 12 months. ]Defined as the date of development of new metastases, excluding oligometastasis diagnosed at enrolment.
- Overall response [ Time Frame: Assessed from the start of protocol treatment across all time points until the end of protocol treatment, for up to 12 months. ]Defined as best overall response [complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.
- Duration of response [ Time Frame: Assessed from the date of enrolment for up to 12 months. ]Defined as the interval from the date of first documentation of objective response (CR or PR), according to RECIST 1.1 criteria to the date of first documented progression or response.
- Symptom-specific and global quality of life: The Lung Cancer Symptom Scale [ Time Frame: Assessed at trial entry, until 6 months after treatment start and at 12 months from enrolment. ]The Lung Cancer Symptom Scale, a 9-item one page questionnaire will be used to assess change in total score (average of all 9 items).
- Toxicity before and after surgery/radiotherapy [ Time Frame: Adverse events will be collected from the date of consent until 90 days after the completion of treatment. ]Safety parameters will be assessed in terms of adverse events graded by CTCAE v5.0 including events leading to dose interruptions, withdrawals of protocol treatment and death; severe, serious and selected adverse events; deaths; laboratory parameters and abnormalities, and vital signs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965468
|Contact: Barbara Ruepp, PharmDfirstname.lastname@example.org|
|Maastricht University Medical Center||Not yet recruiting|
|Contact: Lizza Hendriks, MD email@example.com|
|Principal Investigator: Lizza Hendriks, MD|
|Erasmus Medical Centre||Recruiting|
|Contact: Joachim Aerts, MD firstname.lastname@example.org|
|Principal Investigator: Joachim Aerts, MD|
|Hosp. De la Santa Creu i Sant Pau||Recruiting|
|Contact: Ivana Sullivan, MD|
|Principal Investigator: Ivana Sullivan, MD|
|Hosp. Uni. Virgen de las Nieves||Recruiting|
|Contact: Javier Valdivia, MD|
|Principal Investigator: Javier Valdivia, MD|
|Hosp. Sanchinarro- Centro Integral Oncología Clara Campal||Recruiting|
|Contact: Beatriz Jimenez Munarriz, MD|
|Principal Investigator: Beatriz Jimenez Munarriz, MD|
|Hosp. Uni. Politécnico La Fe||Not yet recruiting|
|Contact: Oscar Juan-Vidal, MD|
|Principal Investigator: Oscar Juan-Vidal, MD|
|Contact: Amina Scherz, MD email@example.com|
|Principal Investigator: Amina Scherz, MD|
|Geneva University Hospital||Recruiting|
|Contact: Alfredo Addeo, MD firstname.lastname@example.org|
|Principal Investigator: Alfredo Addeo, MD|
|Centre Hospitalier Universitaire Vaudois (CHUV)||Recruiting|
|Contact: Solage Peters|
|Principal Investigator: Solange Peters, MD|
|University Hospital Zurich||Recruiting|
|Contact: Matthias Guckenberger, MD Matthias.Guckenberger@usz.ch|
|Principal Investigator: Matthias Guckenberger, MD|
|Study Chair:||Matthias Guckenberger, MD-PhD||University Hospital, Zürich|
|Study Chair:||Isabelle Schmitt-Opitz, MD||University Hospital, Zürich|