Clinical trial · Interventional
To Determine Safe and Effective Dose of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Participants With Advanced Non-small Cell Lung Cancer
An Open-Label Randomized, Phase 2A, Dose-Ranging Study of Sotatercept (ACE-011) for Chemotherapy-Induced Anemia in Subjects With Advanced or Metastatic Solid Tumors Treated With Platinum-Based Chemotherapeutic Regimens
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Persistent low enrollment made study continuation no longer feasible
Summary
Brief summary (as posted)
The purpose of this study was to determine an effective and safe dose of sotatercept (ACE-011) for the treatment of chemotherapy-induced anemia (CIA) in participants with metastatic non-small cell lung cancer (NSCLC) who are being treated with first-line platinum based chemotherapy.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Cancer of Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Carcinoma, Small-Cell Lung | Lung Small Cell Carcinoma | ALIAS | 0.90 |
| Uterine Cervical Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sotatercept 15 mg | Drug | — | UNRESOLVED |
| Sotatercept 30 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sotatercept 15 mg
- description
- Participants will receive sotatercept 15 mg by subcutaneous (SC) injection once every 42 days, up to four doses.
- interventionNames
- Drug: Sotatercept 15 mg
- type
- EXPERIMENTAL
- label
- Sotatercept 30 mg
- description
- Participants will receive sotatercept 30 mg by SC injection once every 42 days, up to four doses.
- interventionNames
- Drug: Sotatercept 30 mg
Primary outcomes (1)
- measure
- Number of Participants Who Experienced a Hematopoietic Response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
1. Men and women \>18 years of age
2. Part 1: Histologically confirmed (cytology or biopsy) solid tumor malignancy, excluding those solid tumors treated with curative intent.
Part 2: Histologically confirmed non-small cell lung cancer
3. Documented metastatic disease
4. Measurable or non-measurable disease evaluable by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
5. All of the following laboratory values:
* Hemoglobin ≥6.5 to \<11.0 g/dL (≥65 to \<110 g/L), due to chemotherapy-induced anemia
* Absolute neutrophil count ≥500/mm\^3
* Platelet count ≥75,000/mm\^3 (\>2 hours since prior platelet transfusion
* Adequate renal function
* creatinine clearance ≥40mL/min or ≥50 mL/min if cisplatin is concomitantly administered and
* urine protein / creatinine ratio ≤1.0; or ≤2.0 if bevacizumab (Avastin®) is concomitantly administered
* Hepatic function (bilirubin \<1.5 x upper limits of normal (ULN); AST and ALT \<3.0 x ULN and ≤5.0 ULN for participants with liver metastases)
6. Participants must have received:
* at least one cycle and up to 4 cycles (q3w schedule) of platinum-based chemotherapy and be randomized prior to receiving Cycle 5 OR
* at least one cycle and up to 3 months (depending upon regimen) of platinum-based chemotherapy
7. \>28 days since previous treatment with ESA
8. \>14 days since last red blood cell transfusions
9. Eastern Oncology Cooperative Group (ECOG) Performance status 0-2
10. For females of childbearing potential, highly effective method of birth control for at least 28 days before starting study, during participation and at least 112 days following last dose of sotatercept
11. Males must use latex condom or non-latex condom not made of (animal) membrane during any sexual contact with female of childbearing potential
12. Life expectancy of \>3 months
13. Willing to adhere to study visit schedule
14. Understand and voluntarily sign informed consent
Exclusion Criteria:
Part 2 only, history of prior regimen(s)of platinum-based chemotherapy for metastatic NSCLC and/or history of adjuvant platinum-based chemotherapy with last dose received less than six months prior to the start of current first-line platinum-based chemotherapy for metastatic NSCLC.
1. National Cancer Institute Common Terminology for Adverse Events Grade \>3 toxicity
2. Prior radiation to \>20% of whole skeleton
3. Prior regimen(s) of platinum based chemotherapy for metastatic disease and/or history of adjuvant platinum-based chemotherapy with the last dose received less than six months prior to the start of current first-line platinum-based chemotherapy for metastatic disease
4. Central nervous system metastases
5. Clinically significant pulmonary, endocrine, neurologic, gastrointestinal, hepatic, or genitourinary disease unrelated to underlying malignancy
6. Classification of 3 or higher heart failure (as classified by New York Heart Association)
7. History of thrombosis, deep vein thrombosis, pulmonary emboli, or embolic stroke, if not stable on anticoagulants and/or one of these events occurring in past 6 months
8. Diagnosis of a myeloid malignancy or known history of myelodysplasia
9. Recent history (within 14 days of Day 1) of IV/oral antibiotics due to post septic episode
10. Uncontrolled hypertension. Controlled hypertension is considered clinically stable, and systolic blood pressure (SBP) must be \<150 mmHg and diastolic blood pressure (DBP) must be \< 00 mmHg.
11. Known human immunodeficiency virus (HIV)
12. Known active hepatitis B or C antibody
13. Iron deficiency
14. History of anemia as a result of inherited hemoglobinopathy
15. History of anemia due to autoimmune or hereditary hemolysis or gastrointestinal bleeding
16. Received treatment with another investigational drug or device within 28 days prior to Day 1, or if the half life of the previous product is known, within 5 times the half life prior to dosing, whichever may be longer.
17. Any prior use of sotatercept.
18. Pregnant or lactating females or females planning to become pregnant
19. History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product (Refer to the Investigator's Brochure for further information).
20. Major surgery within 30 days prior to Day 1 (participants must have completely recovered from any previous surgery prior to Day 1).References
Publications (1)
- RESULTRaftopoulos H, Laadem A, Hesketh PJ, Goldschmidt J, Gabrail N, Osborne C, Ali M, Sherman ML, Wang D, Glaspy JA, Puccio-Pick M, Zou J, Crawford J. Sotatercept (ACE-011) for the treatment of chemotherapy-induced anemia in patients with metastatic breast cancer or advanced or metastatic solid tumors treated with platinum-based chemotherapeutic regimens: results from two phase 2 studies. Support Care Cancer. 2016 Apr;24(4):1517-25. doi: 10.1007/s00520-015-2929-9. Epub 2015 Sep 14. PMID 26370220