Phase 2 Study of EC145 Alone Versus EC145+Docetaxel Versus Docetaxel Alone in Participants With FR(++) 2nd Line Non Small Cell Lung Cancer

1. Ability to sign an approved informed consent form (ICF).

2. Must be ≥ 18 years of age.

3. Histology confirmed diagnosis of non-small cell lung cancer (adenocarcinoma, squamous, adenosquamous, or adenocarcinoma with other NSCLC variants of the lung) (Stage IIIB or IV).

4. All (RECIST v1.1-defined) target lesions positive for the folate receptor \[FR(++)\] by SPECT scan.

5. Only one prior systemic therapy for advanced disease (e.g.,a platinum doublet or a maintenance regimen that includes a platinum doublet; in addition, the participant may have received an epidermal growth factor receptor \[EGFR\] inhibitor).

6. Radiological evaluation conducted no more than 28 days prior to beginning study therapy. If history of CNS metastasis baseline radiological imaging must include brain MRI or CT.

7. Radiologic evidence of disease progression following the most recent prior treatment.

8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

9. Must have recovered (to baseline/stabilization) from prior cytotoxic-therapy-associated acute toxicities.

10. Prior radiation therapy is allowed if the following criteria is met:

* Radiation to \< 25% of the bone marrow; whole pelvis radiation is excluded.

* Prior radiotherapy must be completed at least 2 weeks before randomization.

* Must have recovered from the acute toxic effects of the treatment before randomized.

* Prior thoracic radiation must be completed 30 days before study enrollment.

* Irradiated pulmonary lesions cannot be used as target or non-target lesions (and must be excluded) unless there is previous documented progression of these lesions.

* Palliative extrathoracic radiotherapy can continue, but these lesions must be excluded as target and non-target lesions.

11. Adequate organ function:

* Bone marrow reserve: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. Platelets ≥ 100 x 109/L. Hemoglobin ≥ 9 g/dL.

* Hepatic: Total bilirubin ≤ 1.5 x the upper limit of normal (ULN). Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), and lactate dehydrogenase (LDH) and alkaline phosphatase ≤ 2.5 x ULN.

* Renal: Serum creatinine ≤ 1.5 x ULN, or for participants with serum creatinine \> 1.5 ULN, creatinine clearance ≥ 50 mL/min/1.73 m2 (50mL/min/1.73m2 is equivalent to 0.83 mL/s/m2).

12. Participants of childbearing potential:

* Women who are capable of becoming pregnant must have a negative serum pregnancy test within 1 week prior to exposure to EC20 and within 1 week prior to exposure to treatment with EC145 and/or docetaxel.

* Women who are capable of becoming pregnant and male participants who are sexually active must practice an effective method of birth control for the duration of their participation in the trial through 3 months following the last dose of EC145 and through 6 months following the last dose of docetaxel.

What this study is about