To Determine Safe and Effective Dose of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Participants With Advanced Non-small Cell Lung Cancer
Condition: Anemia; Carcinoma, Non-Small-Cell Lung; Carcinoma, Small-Cell Lung; Bladder Cancer; Cancer of Head and Neck; Uterine Cervical Cancer
MeSH terms: Carcinoma; Uterine Cervical Neoplasms; Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms; Carcinoma, Small Cell; Small Cell Lung Carcinoma; Anemia
Intervention: Sotatercept 15 mg; Sotatercept 30 mg
Intervention description: Sotatercept 15 mg SC injection once every 42 days, up to four doses; Sotatercept 30 mg SC injection once every 42 days, up to four doses
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chemotherapy induced anemia; Non-small cell lung cancer

Summary:

      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.
    

Eligibility criteria:

        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).