An Efficacy and Safety Study to Assess [18F]-ML-10 in Detecting Response of Tumors to Chemotherapy and Radiation

Inclusion Criteria:

Male or female patients with either:

Newly diagnosed non small cell lung cancer (NSCLC) (Group A) who meet the following
criteria:

- Previously untreated, histologically or cytologically confirmed stage IIB, IIIA or
IIIB disease, without evidence of distant metastases

- A measurable primary tumor with at least one diameter > 2 cm or primary tumor
extending to one or more lymph nodes which cannot be distinctively delineated as
confirmed by a diagnostic quality chest CT performed within 4 weeks prior to
initiation of the concurrent CRT.

- Planned to receive concurrent chemoradiotherapy as definitive treatment. The
radiation dose should not exceed 70 Gy.

- Undergone the following minimum workup to confirm disease staging within 4 weeks
prior to initiation of the concurrent CRT:

- GBCA-enhanced Brain MRI or contrast enhanced CT if there are signs or symptoms
suggesting brain metastases within the past 2 months.

- If necessary to confirm stage of disease, an upper abdomen CT scan will be
performed.

- whole-body FDG PET/CT; OR

- Newly diagnosed squamous cell carcinoma of the head and neck (SCCHN) (Group B) who
meet the following criteria:

- Previously untreated, histologically or cytologically confirmed (from the
primary tumor and/or lymph nodes) stage III-IV disease without evidence of
distant metastases.

- A measurable (i) primary tumor with at least one diameter ≥2 cm and (ii) lymph
node with at least one diameter ≥ 2 cm as confirmed by a diagnostic quality neck
CT performed within 4 weeks prior to initiation of the concurrent CRT.

- Planned to receive concurrent chemoradiotherapy as definitive treatment. The
radiation dose should not exceed 70 Gy.

- Have undergone the following minimum workup to confirm disease staging within 4
weeks prior to initiation of the concurrent CRT:

- Whole-body FDG PET/CT.

- Patients ≥ 18 years of age.

- Able to comply with lying still during the PET/CT imaging session which may last for
up to 3 hrs with intermediate breaks.

- ECOG performance status of 0, 1 or 2.

- Adequate renal function and adequate hepatic function, as assessed by standard
laboratory criteria and defined as:

- Serum creatinine ≤ 1.2 times the Upper Limit of Normal (ULN).

- Total bilirubin ≤ 1.5 times the ULN.

- Asparagine aminotransferase (AST) and/or alanineaminotransferase (ALT) ≤ 2.5 times
the ULN (grade 1 according to the NCI-CTCAE v.3).

- Women of child-bearing potential must have a negative blood pregnancy test at
screening and use an adequate and medically acceptable contraceptive method.

- Willing and able to comply with the protocol requirements.

- Able to provide written informed consent.

Exclusion Criteria:

Exclusion criteria specific to patients with NSCLC (Group A):

- Predominant small cell carcinoma histology.

- Pure bronchioalveolar cell carcinoma histology.

- Treatment planned with chemotherapy other than a platinum-based doublet regimen.

- Malignant pleural or pericardial effusions.

- Any contraindication to perform CT with IV contrast agent.

Exclusion criteria specific to patients with SCCHN (Group B):

- Histology other than squamous cell carcinoma.

- Treatment planned with chemotherapy other than a platinum-based regimen.

- Treatment planned with cetuximab.

- Treatment with induction chemotherapy.

- Any contraindication to CT with IV contrast agent.

- Evidence of distant metastases.

- Patients who, based on the investigator's judgment, have other unstable medical
conditions that may preclude safe and complete study participation.

- Treatment with any investigational drug, device or biologic agent within 30 days
prior to administration of [18F]-ML-10.

- Pregnancy or lactation.