Trial · NCT02567799

BIO 300 Non-Small Cell Lung Cancer Study

NCT02567799, Phase 1, Phase 2, Completed, Humanetics Corporation; results first posted 2023-12-20

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. BIO 300 Non-Small Cell Lung Cancer Study. Trials, record NCT02567799. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02567799

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: BIO 300 Non-Small Cell Lung Cancer Study
NCT number: NCT02567799
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 21 participants, actual
Lead sponsor: Humanetics Corporation
Conditions: Carcinoma, Non-Small-Cell Lung
Interventions: BIO 300 Oral Suspension, Paclitaxel, Carboplatin, Radiotherapy
First posted: 2015-10-05
Last updated: 2024-01-25
Results first posted: 2023-12-20

Source ClinicalTrials.gov

Registered outcomes22

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With BIO 300 Oral Suspension-related Dose Limiting Toxicity	Day 1 up to 6 weeks or maximum tolerated dose	Adverse events of CTCAE v4.0 grade 3 or higher that were possibly, probably or definitely related to BIO 300 Oral Suspension and have occurred before or during concurrent chemoradiotherapy were considered dose limiting toxicities.
Secondary	Number of Participants With Adverse Events Throughout the Study	Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants.
Secondary	Mean Maximum Serum Concentration (Cmax) of BIO 300 Administered in the Absence of Chemotherapy	Day 1, prior to 1st dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post dose
Secondary	Mean Area Under the Serum Concentration Curve (AUC) of BIO 300 Administered in the Absence of Chemotherapy	Day 1, prior to 1st dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post dose
Secondary	Mean Maximum Serum Concentration (Cmax) of BIO 300 When Administered in Combination With Paclitaxel and Carboplatin	Week 1 or 2, during the 1st or 2nd chemotherapy infusion, prior to 1st dose then 0.5, 1, 2, 3, 4, 8, and 24 hours post dose
Secondary	Mean Area Under the Serum Concentration Curve (AUC) of BIO 300 When Administered in Combination With Paclitaxel and Carboplatin	Week 1 or 2, during the 1st or 2nd chemotherapy infusion, prior to 1st dose then 0.5, 1, 2, 3, 4, 8, and 24 hours post dose
Secondary	Mean Maximum Serum Concentration (Cmax) of Paclitaxel When Administered in Combination With BIO 300	Week 1 or 2, during the 1st or 2nd chemotherapy infusion, prior to BIO 300 dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post initial dose
Secondary	Mean Area Under the Serum Concentration Curve (AUC) of Paclitaxel When Administered in Combination With BIO 300	Week 1 or 2, during the 1st or 2nd chemotherapy infusion, prior to BIO 300 dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post initial dose
Secondary	Mean Maximum Serum Concentration (Cmax) of Carboplatin When Administered in Combination With BIO 300	Week 1 or 2, during the 1st or 2nd chemotherapy infusion, prior to BIO 300 dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post initial dose
Secondary	Mean Area Under the Serum Concentration Curve (AUC) of Carboplatin When Administered in Combination With BIO 300	Week1 or 2, during the 1st or 2nd chemotherapy infusion, prior to BIO 300 dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post initial dose

1 to 10 of 22Source ClinicalTrials.gov

See all 22 registered outcomes

Outcomes22

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With BIO 300 Oral Suspension-related Dose Limiting Toxicity	Day 1 up to 6 weeks or maximum tolerated dose		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Adverse Events Throughout the Study	Day 1 up to month 13 post radiation or 12 months post chemotherapy consolidation for surgical participants.		Participants	NUMBER
SECONDARY	Mean Maximum Serum Concentration (Cmax) of BIO 300 Administered in the Absence of Chemotherapy	Day 1, prior to 1st dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post dose	Only participants that had blood draws for pharmacokinetics were analyzed	ng/mL	MEAN
SECONDARY	Mean Area Under the Serum Concentration Curve (AUC) of BIO 300 Administered in the Absence of Chemotherapy	Day 1, prior to 1st dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post dose	Only participants that had blood draws for pharmacokinetics were analyzed	ng*hr/mL	MEAN
SECONDARY	Mean Maximum Serum Concentration (Cmax) of BIO 300 When Administered in Combination With Paclitaxel and Carboplatin	Week 1 or 2, during the 1st or 2nd chemotherapy infusion, prior to 1st dose then 0.5, 1, 2, 3, 4, 8, and 24 hours post dose	Only participants that had blood draws for pharmacokinetics were analyzed	ng/mL	MEAN
SECONDARY	Mean Area Under the Serum Concentration Curve (AUC) of BIO 300 When Administered in Combination With Paclitaxel and Carboplatin	Week 1 or 2, during the 1st or 2nd chemotherapy infusion, prior to 1st dose then 0.5, 1, 2, 3, 4, 8, and 24 hours post dose	Only participants that had blood draws for pharmacokinetics were analyzed	ng*hr/mL	MEAN
SECONDARY	Mean Maximum Serum Concentration (Cmax) of Paclitaxel When Administered in Combination With BIO 300	Week 1 or 2, during the 1st or 2nd chemotherapy infusion, prior to BIO 300 dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post initial dose	Only participants that had blood draws for pharmacokinetics were analyzed	ng/mL	MEAN
SECONDARY	Mean Area Under the Serum Concentration Curve (AUC) of Paclitaxel When Administered in Combination With BIO 300	Week 1 or 2, during the 1st or 2nd chemotherapy infusion, prior to BIO 300 dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post initial dose	Only participants that had blood draws for pharmacokinetics were analyzed	ng*hr/mL	MEAN
SECONDARY	Mean Maximum Serum Concentration (Cmax) of Carboplatin When Administered in Combination With BIO 300	Week 1 or 2, during the 1st or 2nd chemotherapy infusion, prior to BIO 300 dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post initial dose	Only participants that had blood draws for pharmacokinetics were analyzed	ng/mL	MEAN
SECONDARY	Mean Area Under the Serum Concentration Curve (AUC) of Carboplatin When Administered in Combination With BIO 300	Week1 or 2, during the 1st or 2nd chemotherapy infusion, prior to BIO 300 dose then 0.5, 1, 2, 3, 4, 8 and 24 hours post initial dose	Only participants that had blood draws for pharmacokinetics were analyzed	ng*hr/mL	MEAN

1 to 10 of 22Source ClinicalTrials.gov

See all 22 outcomes

Results by group182

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With BIO 300 Oral Suspension-related Dose Limiting Toxicity	BIO 300 Oral Suspension (500 mg/Day)	Number of Participants Experiencing DLTs	0		Participants
Number of Participants With BIO 300 Oral Suspension-related Dose Limiting Toxicity	BIO 300 Oral Suspension (1000 mg/Day)	Number of Participants Experiencing DLTs	0		Participants
Number of Participants With BIO 300 Oral Suspension-related Dose Limiting Toxicity	BIO 300 Oral Suspension (1500 mg/Day)	Number of Participants Experiencing DLTs	0		Participants
Number of Participants With BIO 300 Oral Suspension-related Dose Limiting Toxicity	BIO 300 Oral Suspension (500 mg/Day)	Number of Participants That Did Not Experience a DLT	6		Participants
Number of Participants With BIO 300 Oral Suspension-related Dose Limiting Toxicity	BIO 300 Oral Suspension (1000 mg/Day)	Number of Participants That Did Not Experience a DLT	7		Participants
Number of Participants With BIO 300 Oral Suspension-related Dose Limiting Toxicity	BIO 300 Oral Suspension (1500 mg/Day)	Number of Participants That Did Not Experience a DLT	7		Participants
Number of Participants With Adverse Events Throughout the Study	BIO 300 Oral Suspension (500 mg/Day)		7		Participants
Number of Participants With Adverse Events Throughout the Study	BIO 300 Oral Suspension (1000 mg/Day)		7		Participants
Number of Participants With Adverse Events Throughout the Study	BIO 300 Oral Suspension (1500 mg/Day)		7		Participants
Mean Maximum Serum Concentration (Cmax) of BIO 300 Administered in the Absence of Chemotherapy	BIO 300 Oral Suspension (500 mg/Day)		174	Standard Deviation 74	ng/mL

1 to 10 of 182Source ClinicalTrials.gov

See all 182 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Concurrent Chemoradiotherapy	STARTED	BIO 300 Oral Suspension (500 mg/Day)	7
Concurrent Chemoradiotherapy	STARTED	BIO 300 Oral Suspension (1000 mg/Day)	7
Concurrent Chemoradiotherapy	STARTED	BIO 300 Oral Suspension (1500 mg/Day)	7
Concurrent Chemoradiotherapy	COMPLETED	BIO 300 Oral Suspension (500 mg/Day)	6
Concurrent Chemoradiotherapy	COMPLETED	BIO 300 Oral Suspension (1000 mg/Day)	4
Concurrent Chemoradiotherapy	COMPLETED	BIO 300 Oral Suspension (1500 mg/Day)	6
Concurrent Chemoradiotherapy	NOT COMPLETED	BIO 300 Oral Suspension (500 mg/Day)	1
Concurrent Chemoradiotherapy	NOT COMPLETED	BIO 300 Oral Suspension (1000 mg/Day)	3
Concurrent Chemoradiotherapy	NOT COMPLETED	BIO 300 Oral Suspension (1500 mg/Day)	1
Follow-up	STARTED	BIO 300 Oral Suspension (500 mg/Day)	6

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events168

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Constipation	Gastrointestinal disorders	BIO 300 Oral Suspension (500 mg/Day)	2	7	2
other	Constipation	Gastrointestinal disorders	BIO 300 Oral Suspension (1000 mg/Day)	3	7	3
other	Constipation	Gastrointestinal disorders	BIO 300 Oral Suspension (1500 mg/Day)	1	7	1
other	Dyspepsia	Gastrointestinal disorders	BIO 300 Oral Suspension (500 mg/Day)	2	7	2
other	Dyspepsia	Gastrointestinal disorders	BIO 300 Oral Suspension (1000 mg/Day)	1	7	1
other	Dyspepsia	Gastrointestinal disorders	BIO 300 Oral Suspension (1500 mg/Day)	2	7	2
other	Dysphagia	Gastrointestinal disorders	BIO 300 Oral Suspension (500 mg/Day)	2	7	2
other	Dysphagia	Gastrointestinal disorders	BIO 300 Oral Suspension (1000 mg/Day)	2	7	2
other	Dysphagia	Gastrointestinal disorders	BIO 300 Oral Suspension (1500 mg/Day)	3	7	3
other	Diarrhea	Gastrointestinal disorders	BIO 300 Oral Suspension (500 mg/Day)	2	7	2

1 to 10 of 168Source ClinicalTrials.gov

See all 168 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	BIO 300 Oral Suspension (500 mg/Day)	2	7
Total, all-cause mortality	BIO 300 Oral Suspension (1000 mg/Day)	0	7
Total, all-cause mortality	BIO 300 Oral Suspension (1500 mg/Day)	1	7
Total, other adverse events	BIO 300 Oral Suspension (500 mg/Day)	7	7
Total, other adverse events	BIO 300 Oral Suspension (1000 mg/Day)	7	7
Total, other adverse events	BIO 300 Oral Suspension (1500 mg/Day)	7	7
Total, serious adverse events	BIO 300 Oral Suspension (500 mg/Day)	3	7
Total, serious adverse events	BIO 300 Oral Suspension (1000 mg/Day)	1	7
Total, serious adverse events	BIO 300 Oral Suspension (1500 mg/Day)	2	7

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28489488	DERIVED	PubMed
37652301	BACKGROUND	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02567799

GET https://conductscience.org/api/trials/v1/NCT02567799/registered?page=2

API reference For AI assistants