Many Clinical Trial Options Exist for Small Cell Lung Cancer Patients

Dr. Cathy Pietanza

Small cell lung cancer (SCLC) patients badly need new treatment options because the ones they have have not changed in almost 40 years. But a renewed interest in SCLC has led to an increase in research and the development of clinical trials testing new drugs. The links below beginning with "NCT" (National Clinical Trial) will provide more information that you can take to your doctor.

- Alisertib, an aurora kinase A inhibitor, is being studied with paclitaxel in the second line (NCT02038647); early trials using the drug showed activity and in particular, pre-clinical work has shown that tumors with MYC alterations may be most sensitive to Aurora Kinase inhibitors.

- Fibroblast growth factor receptor 1 (FGFR1) is amplified in 6% of small cell lung cancer and there are clinical studies evaluating drugs targeting the FGFR family members for SCLC patients, including the experimental drug JNJ 42756493 (NCT01703481).

- SCLC is known to have many abnormalities in DNA damage repair proteins and genes. One protein being studied is PARP, which is over-expressed in SCLC. There are active studies evaluating the PARP inhibitors, talazoparib and veliparib either alone or in combination with chemotherapy for the treatment of SCLC (NCT01286987, NCT01642251, NCT02289690, and NCT01638546). Olaparib, another PARP inhibitor, is being evaluated with temozolomide in the setting of a phase II clinical trial (NCT02446704).

The immune checkpoint inhibitors, nivolumab and pembrolizumab, have been FDA-approved for the treatment of non-small cell lung cancer. Early studies using these agents in SCLC have showed encouraging and prolonged response rates.  There are numerous studies using immune checkpoint inhibitors that are currently open or about to launch. These drugs are being studied as:

- Maintenance treatment (NCT02538666 and NCT02359019);
- In the second line setting (NCT02481830);
- With radiation therapy (NCT02402920); or
- After several lines of therapy (NCT01928394NCT02261220, and NCT02472977).

Recently, results from a phase I/Ib study showed impressive activity in the second- and third- line setting for an antibody drug conjugate, rovalpituzumab tesirine, especially in the subset of patients whose tumors had high expression of the delta-like protein 3, which the drug targets. Phase II studies with rovalpituzumab tesirine are planned and likely will be available in 2016. A phase I study evaluating a similar compound is actively recruiting patients (NCT02500914).  

The studies highlighted above do not represent an inclusive list, but they do show that there are many trials searching for better answers for small cell lung cancer. Hopefully, the findings from these studies will begin to change the prognosis for patients with this disease. 

Please consider a clinical trial at some point during your treatment.



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