Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517490-24 | Other Identifier | EU CT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Small cell lung cancer (SCLC) is characterized by aggressive and rapid growth and a tendency to develop early spread to distant sites including mediastinal lymph nodes, liver, bones, adrenal glands, and brain. The purpose of this study is to assess safety, dose, change in disease activity of ABBV-706 given with atezolizumab, compared to standard of care (SOC) treatment (etoposide, carboplatin, atezolizumab, and optional lurbinectedin).
ABBV-706 is an investigational drug being developed for the treatment of SCLC. There are multiple treatment arms in this study. Participants will either receive ABBV-706 given with atezolizumab, at 1 of 2 doses, or SOC. Approximately 180 adult participants will be enrolled in the study across sites worldwide.
In the safety lead-in, participants with SCLC will receive intravenous (IV) ABBV-706 in 1 of 2 doses with IV atezolizumab, or IV SOC. In the expansion portion of the study, participants with SCLC will receive IV ABBV-706 in 1 of 2 doses with atezolizumab, or IV SOC, until the optimal dose of ABBV-706 is determined. The estimated duration of the study is up to 69.5 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety Lead-In: ABBV-706 Dose A | Experimental | Participants will receive ABBV-706 dose A in combination with atezolizumab, as part of the approximately 69.5 month study duration. |
|
| Safety Lead-In: ABBV-706 Dose B | Experimental | Participants will receive ABBV-706 dose B in combination with atezolizumab, as part of the approximately 69.5 month study duration. |
|
| Safety Lead-In: Stand of Care (SOC) | Experimental | Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration. |
|
| Expansion: ABBV-706 Dose A | Experimental | Participants will receive ABBV-706 dose A in combination with atezolizumab, as part of the approximately 69.5 month study duration. |
|
| Expansion: ABBV-706 Dose B | Experimental | Participants will receive ABBV-706 dose B in combination with atezolizumab, as part of the approximately 69.5 month study duration. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-706 | Drug | Intravenous (IV) Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AE)s | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to 69.5 Months |
| Progression-Free Survival (PFS) Based on Investigator Assessment | PFS is defined as the time from randomization to the first documentation of radiological progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator or death from any cause, whichever occurs first. | Up to Approximately 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response (OR) as Measured by Overall Response Rate (ORR) Based on Investigator Assessment | OR is defined as participants achieving a best overall response (BOR) of confirmed complete response (CR)/partial response (PR) per RECIST v1.1 as determined by investigator prior to initiation of subsequent anti-cancer therapy. OR will be summarized by ORR, defined as the proportion of subjects achieving OR and will be summarized for each arm with its associated 95% confidence interval (CI). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine /ID# 278181 | Recruiting | New Haven | Connecticut | 06510 | United States | |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Expansion: SOC | Experimental | Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration. |
|
| Atezolizumab | Drug | IV Infusion |
|
| Etoposide | Drug | IV Infusion |
|
| Carboplatin | Drug | IV Injection |
|
| Carboplatin | Drug | IV Infusion |
|
| Lurbinectedin | Drug | IV Infusion |
|
| Up to Approximately 24 Months |
| Duration of Response (DoR) Based on Investigator Assessment | DoR is defined as time from the initial response of CR/PR until the first documentation of radiographical PD according to RECIST v1.1 by investigator or death from any cause, whichever occurs first. | Up to Approximately 24 Months |
| Disease Control (DC) Based on Investigator Assessment | DC is defined as achieving an OR or stable disease (SD) according to RECIST v1.1 by investigator at any time prior to subsequent anti-cancer therapy. | Up to Approximately 24 Months |
| OS | OS, is defined as the time from randomization to death from any cause. | Up to Approximately 28 Months |
| Ocala Oncology Center /ID# 278269 |
| Recruiting |
| Ocala |
| Florida |
| 34474 |
| United States |
| Moffitt Cancer Center /ID# 277573 | Recruiting | Tampa | Florida | 33612 | United States |
| Fort Wayne Medical Oncology And Hematology /ID# 277336 | Recruiting | Fort Wayne | Indiana | 46804 | United States |
| Baptist Health Lexington /ID# 277729 | Recruiting | Lexington | Kentucky | 40503 | United States |
| Dana-Farber Cancer Institute /ID# 277732 | Recruiting | Boston | Massachusetts | 02215 | United States |
| Missouri Cancer Associates /ID# 278299 | Recruiting | Columbia | Missouri | 65201 | United States |
| University Hospitals Cleveland Medical Center /ID# 277556 | Recruiting | Cleveland | Ohio | 44106 | United States |
| The University of Texas MD Anderson Cancer Center /ID# 277929 | Recruiting | Houston | Texas | 77030 | United States |
| Virginia Cancer Specialists - Fairfax /ID# 278298 | Recruiting | Fairfax | Virginia | 22031 | United States |
| Grand Hopital de Charleroi - Les Viviers /ID# 276897 | Recruiting | Charleroi | Hainaut | 6280 | Belgium |
| Groupe Sante CHC - Clinique du MontLegia /ID# 276783 | Recruiting | Liège | Liege | 4000 | Belgium |
| Jessa Ziekenhuis - Campus Virga Jesse /ID# 276781 | Recruiting | Hasselt | Limburg | 3500 | Belgium |
| AZ Maria Middelares /ID# 277027 | Recruiting | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| Cancer Hospital - Chinese Academy of Medical Sciences /ID# 277167 | Recruiting | Beijing | Beijing Municipality | 100021 | China |
| The First affiliated hospital of Nanchang University - Nanchang /ID# 277247 | Recruiting | Nanchang | Jiangxi | 330006 | China |
| Shanghai East Hospital /ID# 277111 | Recruiting | Shanghai | Shanghai Municipality | 200120 | China |
| Shanghai Pulmonary Hospital /ID# 276960 | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
| Lungenfachklinik Immenhausen /ID# 278005 | Recruiting | Immenhausen | Hesse | 34376 | Germany |
|
| Universitaetsklinikum Giessen und Marburg GmbH /ID# 277466 | Recruiting | Marburg | Hesse | 35043 | Germany |
|
| Evangelische Lungenklinik Berlin /ID# 277094 | Recruiting | Berlin | 13125 | Germany |
| Meir Medical Center /ID# 277292 | Recruiting | Kefar Sava | Central District | 4428164 | Israel |
| Assuta Ashdod Medical Center /ID# 276661 | Recruiting | Ashdod | Southern District | 7747600 | Israel |
| The Chaim Sheba Medical Center /ID# 276660 | Recruiting | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Rambam Health Care Campus- Haifa /ID# 276663 | Recruiting | Haifa | 3109601 | Israel |
| Hadassah Medical Center-Hebrew University /ID# 276662 | Recruiting | Jerusalem | 91120 | Israel |
| National Cancer Center Hospital East /ID# 277239 | Recruiting | Kashiwa-shi | Chiba | 277-8577 | Japan |
| Shizuoka Cancer Center /ID# 277243 | Recruiting | Sunto-gun | Shizuoka | 411-8777 | Japan |
| Tokyo Metropolitan Komagome Hospital /ID# 277335 | Recruiting | Bunkyo Ku | Tokyo | 113-8677 | Japan |
| National Cancer Center Hospital /ID# 277237 | Recruiting | Chuo-Ku | Tokyo | 104-0045 | Japan |
| Wakayama Medical University Hospital /ID# 277260 | Recruiting | Wakayama | Wakayama | 641-8510 | Japan |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 276907 | Recruiting | Poznan | Greater Poland Voivodeship | 60-569 | Poland |
| Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie /ID# 276910 | Recruiting | Lublin | Lublin Voivodeship | 20-090 | Poland |
| Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 277112 | Recruiting | Warsaw | Masovian Voivodeship | 02-781 | Poland |
| University Clinical Center Serbia /ID# 277007 | Recruiting | Belgrade | Beograd | 11000 | Serbia |
| Clinical Hospital Center - Bežanijska Kosa /ID# 277013 | Recruiting | Belgrade | Beograd | 11080 | Serbia |
| University Clinical Center Nis /ID# 277180 | Recruiting | Niš | Nisavski Okrug | 18300 | Serbia |
| Institute For Pulmonary Diseases Of Vojvodina /ID# 277003 | Recruiting | Kamenitz | Sremski Okrug | 21208 | Serbia |
| University Clinical Center Kragujevac /ID# 277179 | Recruiting | Kragujevac | Sumadijski Okrug | 34000 | Serbia |
| National Cancer Center /ID# 277434 | Recruiting | Goyang-si | Gyeonggido | 10408 | South Korea |
| Chungbuk National University Hospital /ID# 277429 | Recruiting | Cheongju-si | North Chungcheong | 28644 | South Korea |
| Seoul National University Hospital /ID# 277271 | Recruiting | Seoul | Seoul Teugbyeolsi | 03080 | South Korea |
| Yonsei University Health System Severance Hospital /ID# 277597 | Recruiting | Seoul | Seoul Teugbyeolsi | 03722 | South Korea |
| Asan Medical Center /ID# 277603 | Recruiting | Seoul | Seoul Teugbyeolsi | 05505 | South Korea |
| Samsung Medical Center /ID# 277615 | Recruiting | Seoul | Seoul Teugbyeolsi | 06351 | South Korea |
| Complejo Hospitalario Universitario A Coruña /ID# 276922 | Recruiting | A Coruña | A Coruna | 15006 | Spain |
| Hospital Regional Universitario de Malaga /ID# 276927 | Recruiting | Málaga | Andalusia | 29010 | Spain |
| Hospital Clinic de Barcelona /ID# 276878 | Recruiting | Barcelona | 08036 | Spain |
| Hospital Universitario 12 de Octubre /ID# 277251 | Recruiting | Madrid | 28041 | Spain |
| Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277267 | Recruiting | Kaohsiung City | 807 | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital /ID# 277725 | Recruiting | Kaohsiung City | 833 | Taiwan |
| Chung Shan Medical University Hospital /ID# 277660 | Recruiting | Taichung | 402 | Taiwan |
| Taipei Veterans General Hospital /ID# 277263 | Recruiting | Taipei | 112 | Taiwan |
| Linkou Chang Gung Memorial Hospital /ID# 277264 | Recruiting | Taoyuan City | 333 | Taiwan |
| Gazi University Medical Faculty /ID# 276843 | Recruiting | Ankara | 06560 | Turkey (Türkiye) |
| Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 277076 | Recruiting | Ankara | 06620 | Turkey (Türkiye) |
| Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 276839 | Recruiting | Istanbul | 34722 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D005047 | Etoposide |
| D016190 | Carboplatin |
| C568606 | PM 01183 |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D056831 | Coordination Complexes |
Not provided
Not provided