Trial Outcomes & Findings for Study of TH-302 or Placebo in Combination With Pemetrexed in Patients With Non-squamous Non-small Cell Lung Cancer (NCT NCT02093962)
NCT ID: NCT02093962
Last Updated: 2025-05-16
Results Overview
To assess the efficacy of pemetrexed in combination with TH-302 as determined by overall survival in patients with advanced non-squamous NSCLC in the second-line chemotherapy setting compared with pemetrexed in combination with placebo
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
265 participants
Primary outcome timeframe
2 years
Results posted on
2025-05-16
Participant Flow
Participant milestones
| Measure |
TH-302 and Pemetrexed
TH-302 in combination with pemetrexed
TH-302 combination with pemetrexed: 400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration.
|
Placebo and Pemetrexed
Matching placebo in combination with pemetrexed
Matched placebo in combination with pemetrexed: Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration.
|
|---|---|---|
|
Overall Study
STARTED
|
134
|
131
|
|
Overall Study
Received Treatment
|
130
|
130
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
134
|
131
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of TH-302 or Placebo in Combination With Pemetrexed in Patients With Non-squamous Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
TH-302 and Pemetrexed
n=134 Participants
TH-302 in combination with pemetrexed
TH-302 combination with pemetrexed: 400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration.
|
Placebo and Pemetrexed
n=131 Participants
Matching placebo in combination with pemetrexed
Matched placebo in combination with pemetrexed: Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration.
|
Total
n=265 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
81 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
166 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
53 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
115 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
150 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
130 Participants
n=99 Participants
|
126 Participants
n=107 Participants
|
256 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 yearsTo assess the efficacy of pemetrexed in combination with TH-302 as determined by overall survival in patients with advanced non-squamous NSCLC in the second-line chemotherapy setting compared with pemetrexed in combination with placebo
Outcome measures
| Measure |
TH-302 and Pemetrexed
n=134 Participants
TH-302 in combination with pemetrexed
TH-302 combination with pemetrexed: 400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration.
|
Placebo and Pemetrexed
n=131 Participants
Matching placebo in combination with pemetrexed
Matched placebo in combination with pemetrexed: Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration.
|
|---|---|---|
|
Overall Survival
|
51 Participants
|
49 Participants
|
Adverse Events
TH-302 and Pemetrexed
Serious events: 52 serious events
Other events: 130 other events
Deaths: 0 deaths
Placebo and Pemetrexed
Serious events: 72 serious events
Other events: 130 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TH-302 and Pemetrexed
n=130 participants at risk
TH-302 in combination with pemetrexed
TH-302 combination with pemetrexed: 400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration.
|
Placebo and Pemetrexed
n=130 participants at risk
Matching placebo in combination with pemetrexed
Matched placebo in combination with pemetrexed: Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration.
|
|---|---|---|
|
Infections and infestations
Bacteraemia
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Infections and infestations
Bronchitis
|
0.77%
1/130 • Number of events 1
|
0.77%
1/130 • Number of events 1
|
|
Infections and infestations
Erysipelas
|
1.5%
2/130 • Number of events 2
|
0.77%
1/130 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Infections and infestations
Influenza
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Infections and infestations
Lung infection
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Infections and infestations
Pneumonia
|
1.5%
2/130 • Number of events 2
|
3.1%
4/130 • Number of events 4
|
|
Infections and infestations
Pulmonary sepsis
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Infections and infestations
Respiratory tract infection
|
0.77%
1/130 • Number of events 1
|
2.3%
3/130 • Number of events 3
|
|
Infections and infestations
Sepsis
|
0.77%
1/130 • Number of events 1
|
0.77%
1/130 • Number of events 1
|
|
Infections and infestations
Septic shock
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Blood and lymphatic system disorders
Anaemia
|
0.77%
1/130 • Number of events 1
|
5.4%
7/130 • Number of events 11
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.5%
2/130 • Number of events 2
|
2.3%
3/130 • Number of events 3
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.77%
1/130 • Number of events 1
|
0.77%
1/130 • Number of events 1
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Nervous system disorders
Cerebral ischaemia
|
0.77%
1/130 • Number of events 1
|
0.77%
1/130 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.77%
1/130 • Number of events 1
|
0.77%
1/130 • Number of events 1
|
|
Nervous system disorders
Coma
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Nervous system disorders
Convulsion
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Nervous system disorders
Quadriplegia
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Nervous system disorders
Vocal cord paralysis
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.77%
1/130 • Number of events 1
|
0.77%
1/130 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Cardiac disorders
Cardiac failure
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Vascular disorders
Deep vein thrombosis
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Vascular disorders
Embolism
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Vascular disorders
Superior vena cava syndrome
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.77%
1/130 • Number of events 1
|
1.5%
2/130 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.77%
1/130 • Number of events 1
|
0.77%
1/130 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
3/130 • Number of events 3
|
1.5%
2/130 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.8%
5/130 • Number of events 5
|
2.3%
3/130 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/130
|
3.1%
4/130 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Gastrointestinal disorders
Haematemesis
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.77%
1/130 • Number of events 1
|
0.77%
1/130 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.77%
1/130 • Number of events 2
|
0.00%
0/130
|
|
General disorders
Asthenia
|
1.5%
2/130 • Number of events 2
|
1.5%
2/130 • Number of events 2
|
|
General disorders
Chest pain
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
General disorders
General physical health deterioration
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/130
|
3.1%
4/130 • Number of events 4
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
Other adverse events
| Measure |
TH-302 and Pemetrexed
n=130 participants at risk
TH-302 in combination with pemetrexed
TH-302 combination with pemetrexed: 400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration.
|
Placebo and Pemetrexed
n=130 participants at risk
Matching placebo in combination with pemetrexed
Matched placebo in combination with pemetrexed: Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
30.8%
40/130 • Number of events 56
|
38.5%
50/130 • Number of events 80
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.5%
24/130 • Number of events 70
|
23.1%
30/130 • Number of events 83
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.7%
10/130 • Number of events 19
|
19.2%
25/130 • Number of events 47
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.4%
20/130 • Number of events 27
|
13.1%
17/130 • Number of events 27
|
|
Nervous system disorders
Headache
|
12.3%
16/130 • Number of events 20
|
8.5%
11/130 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.6%
19/130 • Number of events 23
|
14.6%
19/130 • Number of events 21
|
|
Gastrointestinal disorders
Diarrhoea
|
12.3%
16/130 • Number of events 24
|
17.7%
23/130 • Number of events 43
|
|
Gastrointestinal disorders
Nausea
|
28.5%
37/130 • Number of events 79
|
30.8%
40/130 • Number of events 76
|
|
Gastrointestinal disorders
Stomatitis
|
13.8%
18/130 • Number of events 26
|
18.5%
24/130 • Number of events 45
|
|
Gastrointestinal disorders
Vomiting
|
13.1%
17/130 • Number of events 20
|
19.2%
25/130 • Number of events 34
|
|
General disorders
Asthenia
|
14.6%
19/130 • Number of events 30
|
21.5%
28/130 • Number of events 48
|
|
General disorders
Fatigue
|
19.2%
25/130 • Number of events 33
|
25.4%
33/130 • Number of events 44
|
|
Investigations
Alanine aminotransferase increased
|
12.3%
16/130 • Number of events 27
|
13.1%
17/130 • Number of events 26
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place