Phase 2
Completed N=80
Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT01671332 ↗Enrolled (actual)
80
Serious AEs
48.4%
Results posted
May 2020
Primary outcomePrimary: Progression-free Survival in Months — 2.8; 1.6 months
Summary
The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival in Months |
2.8; 1.6 | — |
| SECONDARY Response Rate Per RECIST 1.1 Criteria |
1; 3; 17; 11; 17; 25 | — |
| SECONDARY Overall Survival |
5.3; 4.1 | — |
| SECONDARY Number of Participants With Toxicity/Adverse Events From Treatment |
35; 31 | — |
| SECONDARY Evaluation of Peripheral Blood Lymphocytes for DNA Damage-induced Checkpoint Control. |
0.91; 1.30 | — |
Eligibility Criteria
Inclusion Criteria
- Pathologically proven diagnosis of non-small cell lung cancer
- Documented disease progression after first-line chemotherapy for non-small cell lung cancer
- Stable and treated CNS metastasis is allowed
- Radiation must be completed at least 2 weeks prior to starting protocol treatment
- Major surgery must be completed at least 4 weeks prior to starting protocol treatment
- ECOG performance status 0-2
- Sexually active patients must use adequate contraception
- Adequate bone marrow function
- Adequate renal function
- Adequate liver function
Exclusion Criteria
- Severe hypersensitivity reaction to docetaxel
- Pre-existing grade 3 or 4 neuropathy
- Women who are pregnant or breastfeeding
- Uncontrolled intercurrent illness
- Receipt of 3 or more prior chemotherapy regimens
Data sourced from ClinicalTrials.gov (NCT01671332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.