Combination of Atezolizumab With Dendritic Cell Vaccine in Patients With Lung Cancer (NCT04487756) | Clinical Trial Compass
CompletedPhase 1/2
Combination of Atezolizumab With Dendritic Cell Vaccine in Patients With Lung Cancer
Spain20 participantsStarted 2021-03-17
Plain-language summary
This is a single-arm Phase Ib/II multicenter open-label study, with translational sub-study, of atezolizumab plus autologous dendritic cell vaccine as maintenance treatment in extensive-stage small cell lung cancer (ES-SCLC). It is expected that three Spanish sites will include patients in this study.
Patients will receive standard treatment with carboplatin and etoposide, plus atezolizumab for four 21-day cycles (induction phase), followed by a maintenance phase during which they will receive the dendritic cell vaccine (6 doses maximum) in combination with atezolizumab until they had unacceptable toxic effects, disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, or no additional clinical benefit.
The two primary endpoints are the investigator-assessed toxicity and the 6 months PFS, both in the intention-to-treat population. Secondary Outcome Measures include: Duration of clinical benefit (DCB), Overall survival (OS) and Overall response rate (ORR)
The translational substudy will include:
Analysis of tumor tissue samples will consist of PD-L1 Immunohistochemistry testing, RNA expression, Work Environmental Scale (WES) analysis, and flow cytometry in pretreatment fresh tumor tissue.
The analysis will consist of T cell immunophenotyping, DC immunophenotyping, Tumoral RNA analysis by nanostring and tumoral cell-free DNA analysis by WES and cytokine analysis
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histological diagnosis of extensive-stage small cell lung cancer (ES-SCLC). Unequivocally confirmed diagnosis of SCLC by histology preferably including the presence of neuroendocrine features by immunohistochemistry.
. Centrally confirmed tumor tissue viability for vaccine preparation.
. No previous cancer treatment for advanced disease
. Life expectancy at least 16 weeks
. ECOG performance status 0 or 1.
. Adequate normal organ and marrow function as defined below:
. Prior palliative radiotherapy must have been completed at least 2 weeks prior to start the study treatment (subjects may receive localized palliative radiotherapy while receiving study drug).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combined atezolizumab with a dendritic cell vaccine for extensive-stage small cell lung cancer — since it's now completed, has any data been published yet, and what did it show about how long patients went without their cancer progressing at 6 months?
2Because this was a Phase 1/2 trial, the main focus was partly on safety — what kinds of side effects were reported, and how does that safety profile compare to what I might experience with standard treatment options for extensive-stage small cell lung cancer?
3Small cell lung cancer can move quickly, so how would my doctor weigh the option of joining a trial like this against starting standard-of-care chemotherapy or immunotherapy right away?
4Since this trial used a dendritic cell vaccine alongside atezolizumab, which is an immunotherapy drug, are there any particular health conditions I have that might make a combination like this riskier for me personally?
5Now that this trial is completed, are there any follow-on studies or related trials that built on this approach that my doctor thinks might be worth looking into for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-Free Survival (PFS) rate at 6 months
Timeframe: At 6 months after start of treatment
2
Frequency and severity of AEs and SAEs (Safety)
Timeframe: Throughout the study. Approximately 3 years
. Subjects with brain metastases are eligible if they are asymptomatic, are treated, or are neurological stable for at least 2 weeks without the use of steroids, or on a stable or decreasing dose of \< 10 mg daily prednisone or equivalent.
Exclusion criteria
. Prior chemotherapy for extensive-stage ES-SCLC
. Any prior anti-PD-1/PD-L1 antibody therapy
. History of, or significant evidence of risk for, severe chronic inflammatory or autoimmune disease
. Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 2 weeks prior to enrollment (inhaled or topical steroids at standard doses are allowed)
. Human immunodeficiency virus (HIV) seropositivity, active Hepatitis B or C seropositivity
. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol
. Pregnancy or breastfeeding; female patients must be surgically sterile or be postmenopausal for two years or must agree to use effective contraception during the period of treatment and 6 months after; all female patients with reproductive potential must have a negative pregnancy test (serum/urine) within 24 hours from starting the conditioning chemotherapy; the definition of effective contraception will be based on the judgment of the study investigators; patients who are breastfeeding are not allowed on study
. Any unresolved toxicity (CTCAE grade 2) from previous anti-cancer therapy. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripheral neuropathy).