Who is sponsoring NCT02346370?

NCT02346370 is sponsored by Halozyme Therapeutics.

What drugs are being tested in NCT02346370?

Interventions in NCT02346370: PEGylated recombinant human hyaluronidase PH20, Docetaxel.

What condition does NCT02346370 study?

NCT02346370 studies Non-small Cell Lung Cancer.

Is NCT02346370 still recruiting?

NCT02346370 is currently terminated. Last updated 8 February 2019.

Are results published for NCT02346370?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-02-08 · How we verify

NCT02346370: PRIMAL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 1b Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) Combined With Docetaxel in Subjects With Recurrent Previously Treated Locally Advanced or Metastatic NSCLC

Terminated Phase 1 Results posted Last updated 8 February 2019

What this trial tests

Phase 1 trial testing PEGylated recombinant human hyaluronidase PH20 in Non-small Cell Lung Cancer in 16 participants. Terminated before completion.

Timeline

10 February 2015

Primary endpoint
9 August 2016

14 November 2016

Quick facts

Lead sponsor	Halozyme Therapeutics
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	10 February 2015
Primary completion	9 August 2016
Estimated completion	14 November 2016
Sites	8 locations across United States

Drugs / interventions tested

PEGylated recombinant human hyaluronidase PH20 — full drug profile →
Docetaxel (Docetaxel) — full drug profile →

Conditions studied

Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →

Sponsor

Halozyme Therapeutics — full company profile →

Who can join

18 and older, any sex, with Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Dose Limiting Toxicities (DLTs) Primary · Cycle 1 (Day 1 through Day 21) (1 Cycle = 21 days)

DLTs were defined as adverse events (AEs) that occurred during Cycle 1 in the Dose Escalation portion of the study, and deemed by the Investigator as related to study treatment.

Neutropenia

Group	Value	95% CI
Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel	0
Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel	1
Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel	0

Gastroenteritis Escherichia coli

Group	Value	95% CI
Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel	0
Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel	1
Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel	0

Sepsis

Group	Value	95% CI
Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel	0
Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel	1
Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel	0

Deep vein thrombosis

Group	Value	95% CI
Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel	0
Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel	1
Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel	1

Number of Participants With the Indicated Type of Adverse Events for PEGPH20 and Docetaxel Primary · From date of first dose until 30 days after the last dose of study treatment, up to approximately 1 year 10 months

Throughout the Treatment Period, the assessment of safety was based on AEs, including deaths, non-serious AEs, and serious adverse events, AEs leading to discontinuation of study treatment, and results of vital sign measurements and clinical laboratory assessments (including hematology, clinical chemistry, coagulation parameters, and urinalysis). Additionally, thromboembolic (TE) events were deemed by the Sponsor as AEs of special interest. AEs and laboratory values were graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4

AEs greater than or equal to grade 3

Group	Value	95% CI
Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel	5
Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel	4
Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel	3

PEGPH20-related AEs

Group	Value	95% CI
Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel	6
Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel	4
Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel	4

Docetaxel-related AEs

Group	Value	95% CI
Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel	7
Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel	4
Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel	4

AEs with outcome of death

Group	Value	95% CI
Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel	0
Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel	0
Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel	0

SAEs

Group	Value	95% CI
Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel	3
Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel	3
Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel	1

Treatment-related SAEs

Group	Value	95% CI
Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel	1
Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel	2
Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel	1

AEs leading to discontinuation of study drug

Group	Value	95% CI
Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel	1
Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel	1
Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel	2

Adverse events — posted to ClinicalTrials.gov

Time frame: From date of first dose until 30 days after the last dose of study drug, up to approximately 1 year 10 months.. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1: 1.6 ug/kg PEGPH20 + Docetaxel

Serious: 3/7 (43%)

Deaths: 1/7

Cohort 2: 3.0 ug/kg PEGPH20 + Docetaxel

Serious: 3/4 (75%)

Deaths: 3/4

Cohort 3: 2.2 ug/kg PEGPH20 + Docetaxel

Serious: 1/4 (25%)

Deaths: 1/4

Serious adverse events (10 terms)

Reaction	System	Cohort 1: 1.6 ug/kg PEGPH2…	Cohort 2: 3.0 ug/kg PEGPH2…	Cohort 3: 2.2 ug/kg PEGPH2…
Pneumonia	Infections and infestations	—	—	—
Respiratory distress	Respiratory, thoracic and mediastinal disorders	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—
Diverticulitis	Infections and infestations	—	—	—
Gastroenteritis Escherichia coli	Infections and infestations	—	—	—
Sepsis	Infections and infestations	—	—	—
Deep vein thrombosis	Vascular disorders	—	—	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—	—	—
Pericardial effusion	Cardiac disorders	—	—	—

Other adverse events (32 terms — click to expand)

Reaction	System	Cohort 1: 1.6 ug/kg PEGPH2…	Cohort 2: 3.0 ug/kg PEGPH2…	Cohort 3: 2.2 ug/kg PEGPH2…
Fatigue	General disorders	—	—	—
Pyrexia	General disorders	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Oedema peripheral	General disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—
Insomnia	Psychiatric disorders	—	—	—
Bone pain	Musculoskeletal and connective tissue disorders	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Gastroesophageal reflux disease	Gastrointestinal disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Neuropathy Peripheral	Nervous system disorders	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—
Onycholysis	Skin and subcutaneous tissue disorders	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—
Deep vein thrombosis	Vascular disorders	—	—	—
Local swelling	General disorders	—	—	—
Dysphonia	Respiratory, thoracic and mediastinal disorders	—	—	—
Productive cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—	—
Candida infection	Infections and infestations	—	—	—
Sepsis	Infections and infestations	—	—	—
Cushingoid	Endocrine disorders	—	—	—

Most-reported serious reactions: Pneumonia, Respiratory distress, Myalgia, Neutropenia, Diverticulitis, Gastroenteritis Escherichia coli, Sepsis, Deep vein thrombosis.

Data from ClinicalTrials.gov NCT02346370 adverse events section.

Sponsor's own description

A Phase 1b study for participants with Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) to participate in 1 of 2 portions of this study. The first portion is Dose Escalation in which participants are tested with PEGPH20 at various doses (1.6, 3.0, 2.2 and 2.8 micrograms/kilogram (ug/kg)) in addition to dosing with the standard dose of docetaxel (PDoc) of 75 milligrams/meter squared (mg/m\^2) once every 21-day cycle. Based on observations on the safety and tolerability of study treatment from dose escalation cohorts dosed to date (1.6 and 3.0 ug/kg of PEGPH20), two additional dose levels will be tested, 2.2 and 2.8 ug/kg. Up to 30 additional participants may be enrolled to test these dose levels. The second portion of Phase 1b is Cohort Expansion in which the recommended Phase 2 dose (RP2D) of PDoc identified in dose escalation is administered every 21 days to approximately 50 participants with high hyaluronan (HA-high) prospectively measured in their tumor tissue.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting the tumor stroma for cancer therapy.
Xu M, Zhang T, Xia R, Wei Y, et al · · 2022 · cited 195× · PMID 36324128 · DOI 10.1186/s12943-022-01670-1
Recent advances in hyaluronic acid-decorated nanocarriers for targeted cancer therapy.
Wickens JM, Alsaab HO, Kesharwani P, Bhise K, et al · · 2017 · cited 134× · PMID 28017836 · DOI 10.1016/j.drudis.2016.12.009
Modulating the Tumor Microenvironment to Enhance Tumor Nanomedicine Delivery.
Zhang B, Hu Y, Pang Z. · · 2017 · cited 91× · PMID 29311946 · DOI 10.3389/fphar.2017.00952
Tumor battlefield within inflamed, excluded or desert immune phenotypes: the mechanisms and strategies.
Zheng S, Wang W, Shen L, Yao Y, et al · · 2024 · cited 76× · PMID 39107856 · DOI 10.1186/s40164-024-00543-1
Safety and pharmacokinetics of docetaxel in combination with pegvorhyaluronidase alfa in patients with non-small cell lung cancer.
Heineman T, Baumgart M, Nanavati C, Gabrail N, et al · · 2021 · cited 10× · PMID 33982408 · DOI 10.1111/cts.13041

Verify or expand the search:

Other recruiting trials for Non-small Cell Lung Cancer

Currently open trials in the same condition.

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Other Halozyme Therapeutics trials

Trials by the same sponsor.

NCT03267940 — Study of PEGPH20 With Cisplatin (CIS) and Gemcitabine (GEM); PEGPH20 With Atezolizumab (ATEZO), CIS, and GEM; and CIS an · Phase 1 · terminated
NCT02715804 — A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With P · Phase 3 · terminated
NCT02563548 — A Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) With Pembrolizumab in Participants With Selected Hyaluron · Phase 1 · completed
NCT03662334 — A Study of Continuous Subcutaneous Insulin Infusion (CSII) Pump Function in Subjects With Type 1 Diabetes With Recombina · Phase 4 · completed
NCT01839487 — PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02346370 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Halozyme Therapeutics
Last refreshed: 8 February 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02346370.

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