SCLC, Extensive StagePhase 2SPACENCT04221529
Patients With ES-SCLC and ECOG PS=2 Receiving Atezolizumab-Carboplatin-Etoposide
A Phase 2 study testing Atezolizumab in people with SCLC, Extensive Stage, run by AIO-Studien-gGmbH at 19 sites in 2 countries.
Trial summary
Small cell lung cancer (SCLC) is a rapidly proliferating, neuroendocrine tumor that accounts for about 15% of all lung cancers. Most patients have metastases at primary diagnosis involving sites like bone, adrenal glands, liver and brain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCLC, Extensive Stage
- What is being tested?
- Atezolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 6 Jan 2020to 11 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Written informed consent including participation in translational research obtained from the subject prior to performing any protocol-related procedures, including screening evaluations that are not SOC.
- ECOG 2
- At least one measurable tumor lesion (according to RECIST1.1)
- Histologically confirmed small cell lung cancer (SCLC)
- Stage IV disease (according to UICC8)
- No active autoimmune disease
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- Adequate organ function defined as:
- neutrophil count > 1.5 x 109/L
- thrombocytes ≥ 100 x 109/L
- hemoglobin ≥ 9 g/dL
- INR ≤ 1.4 or aPTT ≤ 40 sec during the last 7 days before therapy [Subjects under therapeutic anticoagulation are permitted.]
- bilirubin < 1.5 x ULN
- AST (SGOT)/ALT (SGPT) < 3 x institutional ULN (< 5 x ULN in case of liver metastases)
- creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 45 mL/min
- Availability of tumor tissue/block
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the first dose of IMP.
- Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. [WOCBP should use an adequate method to avoid pregnancy for 6 months after the last dose of IMP.]
- Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving IMP and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 6 months after the last dose of IMP. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men who are azoospermic do not require contraception.
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up.
Who cannot join
- Any preceding systemic anticancer therapy for stage IV SCLC. [Up to one full-cycle-dosing of carboplatin+etoposide chemotherapy within the context of SOC is permitted prior to study treatment.] (Note: Prior treatment for limited stage disease allowed).
- Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lives of previously used trial medication, whichever is longer
- Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-Programmed cell death-ligand 1 (anti-PD-L1), anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor [TNFR] family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Previous treatment in the present study (does not include screening failure).
- Symptomatic CNS metastases. [Patients with asymptomatic brain metastases may be included.]
- Major surgery ≤ 28 days before first dose of study treatment
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- Any uncontrolled systemic disease, condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to:
- known active HBV, HCV or HIV infection [Patients who are HIV-positive are allowed in the trial, so long as they are stable on anti-retroviral therapy, have a CD4 count ≥ 200 cells/μL, and have an undetectable viral load at the time of screening.]
- active tuberculosis
- any other active infection requiring systemic therapy
- history of allogeneic tissue/solid organ transplant
- diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of IMP
- other active malignancy requiring treatment
- clinically significant or symptomatic cardiovascular/cerebrovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before enrolment
- Female subjects who are pregnant, breast-feeding or male/female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year).
- Known hypersensitivity to carboplatin, etoposide or atezolizumab or any of the constituents of the product.
- Medication that is known to interfere with any of the agents applied in the trial.
- Any condition or disease which might interfere with the subject's ability to comply with the study procedures (e.g., dementia).
- Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities [§ 40 Abs. 1 S. 3 Nr. 4 AMG].
- Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
Germany16 sites
St. Josef Hospital
Bochum, 44791
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Niels-Stensen-Kliniken
Georgsmarienhütte, 49124
LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927
Krankenhaus Martha-Maria Halle-Dölau
Halle, 06120
Asklepios Klinik Altona
Hamburg, 22763
Universität Heidelberg
Heidelberg, 69126
Klinikum Löwenstein gGmbH
Löwenstein, 74245
Universitätsklinikum Gießen und Marburg GmbH
Marburg, 35043
Johannes Wesling Klinikum
Minden, 32429
Klinikum der Universität München
München, 80336
Brüderkrankenhaus St. Josef
Paderborn, 33098
Fachkliniken Wangen
Wangen, 88239
Helios Dr. Horst Schmidt Kliniken Wiesbaden
Wiesbaden, 65199
Helios Universitätsklinikum
Wuppertal, 42283
Austria3 sites
Klinikum Klagenfurt
Klagenfurt, 9020
Universitätsklinikum Krems
Krems, 3500
Karl Landsteiner Institut für Lungenforschung und Pneumologische Onkologie c/o Wilhelminenspital der Stadt Wien
Vienna, 1160
About this study
Official title: Single-Arm Phase II-Study in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) With Poor Performance Status Receiving Atezolizumab-Carboplatin-Etoposide
Small cell lung cancer (SCLC) is a rapidly proliferating, neuroendocrine tumor that accounts for about 15% of all lung cancers. Most patients have metastases at primary diagnosis involving sites like bone, adrenal glands, liver and brain.
Compared with non-small-cell lung cancer (NSCLC) SCLC has a unique natural history with a shorter doubling time, higher growth fraction, earlier development of widespread metastases, and uniform initial response to chemo- or radiotherapy.
Read more
The combination of cis- or carboplatin and etoposide is the standard of care in the first-line treatment of stage IV (extensive-disease) SCLC (ED-SCLC). Despite response rates of 50-80%, most patients relapse within six months and the median survival time is less than 10 months. Between 14 and 23% of SCLC patients develop brain metastases.
New cytotoxic agents as well as targeted therapies have not been able to show any improvement of survival in this group of patients.
Early phase trials of PD 1/PD L1-blocking immunotherapeutic agents in patients with recurrent or ED SCLC have shown promising response rates and good tolerability. Immunotherapy may also contribute to the efficacy of systemic treatment by maintaining initial responses to chemotherapy. A double-blind, placebo-controlled phase 3 trial indicates that the addition of atezolizumab to standard chemotherapy significantly improves overall survival and progression-free survival compared with chemotherapy alone in treatment-naïve patients with ED-SCLC who are in good general condition (ECOG 0 or 1). However, about one in three SCLC patients has a poor performance status (ECOG≥2), which is associated with even shorter survival times of under eight months. At present, there is little information regarding the feasibility, safety and efficacy of adding atezolizumab to standard chemotherapy for this considerable fraction of patients.
The investigators expect, that atezolizumab in addition to chemotherapy is feasible in patients with stage IV SCLC and reduced performance status and therefore crucial efficacy data can be acquired in this trial to evaluate a putative Phase III transition in this particular patient population.
- Conditions
- SCLC, Extensive Stage
- Being tested
- Atezolizumab
- Keywords
- Atezolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
1200 mg i.v. on day 1 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| Atezolizumab | Experimental | Four 21-day cycles of induction therapy with atezolizumab+carboplatin+etoposide followed by 21-day cycles of maintenance therapy with atezolizumab. Receives: Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS is defined as the length of time from first dose of experimental IMP (or first dose of chemotherapy, whichever occurs first) to the date of death. A subject who has not died will be censored at last known date alive.
Measured: Measured from first dose of experimental IMP (or first dose of chemotherapy, whichever occurs first) through study completion, an average of one year.
Secondary outcomes (5)
Objective response rate (ORR) (RECIST 1.1)
ORR is defined as the proportion of All Treated Subjects whose best overall response (BOR) from baseline is either a CR or PR per RECIST 1.1 criteria. BOR is determined by the best response designation recorded between the base-line assessment (must precede the date of first dose of IMP) and the date of objectively documented progression. For subjects without documented progression, all available response designations will contribute to the BOR determination. Among All Treated Subjects the ORR (based on investigator assessments according to RECIST 1.1) will be summarized by binomial response rates and their corresponding two-sided 95% exact CIs using Clopper-Pearson method.
Measured: Starting from Screening up to an average of one year.
Progression-free suvival (PFS)
PFS is defined as the time from first dose of IMP to the date of the first documented tumor progression, based on investigator assessments (per RECIST 1.1), or death due to any cause.
Measured: Starting from Screening up to an average of one year.
Incidence of Treatment-Emergent adverse events, serious adverse events and laboratory abnormalities leading to treatment discontinuation
The incidence of treatment-emergent adverse events, serious adverse events and laboratory abnormalities leading to treatment discontinuation will be used as an indicator for safety and tolerability of the IMP. Toxicities in these incidents will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Starting from Screening up to an average of one year.
Quality of life (EORTC-QLQ-C30)
QoL questionnaires (EORTC-QLQ-C30, i.e. European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire with 30 questions for patients with cancer) will be analyzed according to the respective recommendations and manuals (scoring and interpretation materials) issued by the creators of the instruments.
Patients have to answer 28 questions from "not at all" (1) to "very much" (4), where lower scores mean a better outcome. The last two questions range from "very poor" (1) to "excellent" (7), where higher scores mean a better outcome.
Measured: Starting from Screening up to an average of one year.
Quality of life (PRO-CTCAE)
QoL questionnaires (PRO-CTCAE, i.e. Patient Reported Outcome - Common Terminology Criteria for Adverse Events) will be analyzed according to the respective recommendations and manuals (scoring and interpretation materials) issued by the creators of the instruments.
Patients have to answer 22 questions either ranging from "none", "mild", "moderate", "severe" to "very severe" or from "not at all", "a little bit", "somewhat", "quite a bit" to "very much". Lower values mean a better outcome.
Measured: Starting from Screening up to an average of one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start6 Jan 2020
- Primary completion12 Apr 2024
- Study completion11 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLC, Extensive StageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIO-Studien-gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Martin Reck, Prof. Dr., Principal investigator, LungenClinic Grosshansdorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221529
- Sponsor's protocol ID
- AIO-TRK-0119
- Acronym
- SPACE
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2019
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Arm Phase II-Study in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) With Poor Performance Status Receiving Atezolizumab-Carboplatin-Etoposide
- ClinicalTrials.gov ID
- NCT04221529
- Acronym / sponsor ID
- SPACE / AIO-TRK-0119
- Conditions
- SCLC, Extensive Stage
- Keywords
- Atezolizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- AIO-Studien-gGmbHUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 11 Apr 2025 (actual)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Small cell lung cancer (SCLC) is a rapidly proliferating, neuroendocrine tumor that accounts for about 15% of all lung cancers. Most patients have metastases at primary diagnosis involving sites like bone, adrenal glands, liver and brain.
Compared with non-small-cell lung cancer (NSCLC) SCLC has a unique natural history with a shorter doubling time, higher growth fraction, earlier development of widespread metastases, and uniform initial response to chemo- or radiotherapy.
The combination of cis- or carboplatin and etoposide is the standard of care in the first-line treatment of stage IV (extensive-disease) SCLC (ED-SCLC). Despite response rates of 50-80%, most patients relapse within six months and the median survival time is less than 10 months. Between 14 and 23% of SCLC patients develop brain metastases.
New cytotoxic agents as well as targeted therapies have not been able to show any improvement of survival in this group of patients.
Early phase trials of PD 1/PD L1-blocking immunotherapeutic agents in patients with recurrent or ED SCLC have shown promising response rates and good tolerability. Immunotherapy may also contribute to the efficacy of systemic treatment by maintaining initial responses to chemotherapy. A double-blind, placebo-controlled phase 3 trial indicates that the addition of atezolizumab to standard chemotherapy significantly improves overall survival and progression-free survival compared with chemotherapy alone in treatment-naïve patients with ED-SCLC who are in good general condition (ECOG 0 or 1). However, about one in three SCLC patients has a poor performance status (ECOG≥2), which is associated with even shorter survival times of under eight months. At present, there is little information regarding the feasibility, safety and efficacy of adding atezolizumab to standard chemotherapy for this considerable fraction of patients.
The investigators expect, that atezolizumab in addition to chemotherapy is feasible in patients with stage IV SCLC and reduced performance status and therefore crucial efficacy data can be acquired in this trial to evaluate a putative Phase III transition in this particular patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab | Experimental | Drug: AtezolizumabFour 21-day cycles of induction therapy with atezolizumab+carboplatin+etoposide followed by 21-day cycles of maintenance therapy with atezolizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Written informed consent including participation in translational research obtained from the subject prior to performing any protocol-related procedures, including screening evaluations that are not SOC.
- ECOG 2
- At least one measurable tumor lesion (according to RECIST1.1)
- Histologically confirmed small cell lung cancer (SCLC)
- Stage IV disease (according to UICC8)
Key exclusion criteria (20 listed)
- Any preceding systemic anticancer therapy for stage IV SCLC. [Up to one full-cycle-dosing of carboplatin+etoposide chemotherapy within the context of SOC is permitted prior to study treatment.] (Note: Prior treatment for limited stage disease allowed).
- Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lives of previously used trial medication, whichever is longer
- Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-Programmed cell death-ligand 1 (anti-PD-L1), anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor [TNFR] family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Previous treatment in the present study (does not include screening failure).
- Symptomatic CNS metastases. [Patients with asymptomatic brain metastases may be included.]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atezolizumab1200 mg i.v. on day 1 of each cycle | Drug | Atezolizumab |
Primary outcome
Overall survival (OS)
Time frame: Measured from first dose of experimental IMP (or first dose of chemotherapy, whichever occurs first) through study completion, an average of one year.
OS is defined as the length of time from first dose of experimental IMP (or first dose of chemotherapy, whichever occurs first) to the date of death. A subject who has not died will be censored at last known date alive.
5 secondary outcomes
Objective response rate (ORR) (RECIST 1.1)
Time frame: Starting from Screening up to an average of one year.
Progression-free suvival (PFS)
Time frame: Starting from Screening up to an average of one year.
Incidence of Treatment-Emergent adverse events, serious adverse events and laboratory abnormalities leading to treatment discontinuation
Time frame: Starting from Screening up to an average of one year.
Quality of life (EORTC-QLQ-C30)
Time frame: Starting from Screening up to an average of one year.
Quality of life (PRO-CTCAE)
Time frame: Starting from Screening up to an average of one year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- AIO - Working Group for Medical Oncology from the German Cancer SocietyLink provided by the sponsor.
- AIO-Studien-gGmbHLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Reck, Prof. Dr. principal investigator
LungenClinic Grosshansdorf
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atezolizumab in people with SCLC, Extensive Stage, run by AIO-Studien-gGmbH at 19 sites in 2 countries.
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 19 inclusion and 20 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: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany, Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Measured from first dose of experimental IMP (or first dose of chemotherapy, whichever occurs first) through study completion, an average of one year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2025.